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Smartphone telah menjadi bagian tak terpisahkan dari kehidupan manusia. Namun, penggunaan berlebihan dari smartphone dapat membawa dampak negatif dan dapat merugikan penggunanya seperti penurunan fungsi kognitif dan adiksi yang menyebabkan pengguna dapat gagal fokus. Penelitian ini bertujuan untuk mengurangi kurangnya fokus pada remaja baik pelajar SMP, SMA, dan mahasiswa dengan mengimplementasikan sistem fokus timer pomodoro dengan tracking penggunaan smartphone sesuai analisis kebutuhan yang dilakukan terlebih dahulu. Analisa kebutuhan yang dilakukan menitikberatkan pada pembangunan perangkat lunak dengan menentukan kebutuhan pengguna lewat penggalian kebutuhan menggunakan kuisoner yang dilakukan oleh 50 orang dan wawancara terhadap 8 orang. Penelitian ini mengadaptasi metode waterfall dengan tahapan studi kepustakaan, analisis kebutuhan, perancangan, implementasi, pengujian dan analisa, serta kesimpulan dan saran. Pada setiap tahapannya, diintegrasikan konsep gamifikasi sebagai konsep untuk memicu pengguna agar terus menggunakan aplikasi. Digunakan pengembangan cross-platform untuk mempermudah peneliti dalam melakukan pengembangan pada Android. Sistem diuji menggunakan pengujian blackbox menggunakan uji validasi dengan hasil keberhasilan 100%, pengujian usability menggunakan kuisoner SUPR-Qm dengan skor 84,87, dan pengujian compatibility dengan kompatibilitas aplikasi bisa dijalankan pada Android dengan API level 21 sampai API level 29. Abstract Smartphones have become an inseparable part of human life. However, excessive use of smartphones can have negative impacts and can harm users such as decreased cognitive function and addiction which causes users to fail to focus. This study aims to reduce the lack of focus on adolescents, both junior high school, high school, and university students by implementing a pomodoro focus timer system by tracking smartphone usage according to the needs analysis that was carried out beforehand. The software development analysis involved identifying user needs through a questionnaire and interviews with 50 and 8 individuals, respectively.. This research adapts the waterfall method with the stage of literature study, analysis needs, design, implementation, testing and analysis, as well as conclusions and suggestions. At each stage, the concept of gamification is integrated as a concept to trigger users to continue using the application. Cross-platform development is used to make it easier for researchers to develop on Android. The system was tested using blackbox testing using a validation test with 100% success results, usability testing using the SUPR-Qm questionnaire with a score of 84,87, and compatibility testing with application compatibility running on Android with API level 21 to API level 29.

Membaca merupakan proses memahami, menafsirkan, dan mengekstraksi informasi dari serangkaian kata yang memerlukan waktu. Melalui internet, akses membaca semakin luas dengan adanya konten seperti artikel, e-book, jurnal, dan lainnya yang mayoritas disajikan dalam bahasa Inggris. Melalui survei terhadap 30 mahasiswa mengenai kegiatan membaca cepat dan relevansinya terhadap bahasa Inggris, sebanyak 76.7% darinya tidak mengetahui kecepatan membaca mereka dan 56.7% mengaku sering membaca teks berbahasa Inggris. Ada baiknya jika kemampuan membaca cepat dilatih dengan penggunaan bahasa Inggris untuk membangun motivasi terhadap literasi digital yang luas. Melalui pengamatan tersebut, dikembangkan aplikasi berbasis progressive web app (PWA) menggunakan metode SDLC prototyping. Melalui proses prototyping sebanyak 2 kali iterasi, dihasilkan aplikasi PWA ‘Speed Reader’ yang bertujuan untuk membantu berlatih membaca cepat secara senyap dengan materi bacaan berbahasa Inggris. Hasil evaluasi pengujian menunjukkan bahwa aplikasi ini kompatibel pada perangkat mobile dan dapat berjalan secara cross-browser. Setiap fitur berhasil dijalankan dengan tingkat validitas 100% pada pengujian efektivitas. Melalui pengujian efisiensi, didapatkan waktu penyelesaian tugas sebesar 0,156 tugas per detik. Hasil pengujian kepuasan pengguna melalui pengukuran System Usability Scale (SUS) mencapai nilai 84 dengan kategori grade B dan tergolong acceptable. Dengan demikian, dapat disimpulkan bahwa pengguna berhasil mencapai tujuan mereka dan aplikasi ini layak untuk digunakan. Abstract Reading is a process of understanding, interpreting, and extracting information from a series of words that takes time. The internet has significantly broadened reading access, providing abundant content like articles, e-books, journals, predominantly in English. A survey conducted among 30 students explored their engagement in speed reading and its relevance to English. Surprisingly, 76.7% of participants were unaware of their reading speed, while 56.7% acknowledged frequent reading of English texts. To foster extensive digital literacy, it is advisable to train speed reading skills specifically using the English language. Based on this observation, a Progressive Web App (PWA) was developed utilizing the SDLC prototyping method. The development of an app called 'Speed Reader' was aimed to facilitate the practice of silent speed reading with English materials. Evaluation tests demonstrated the application's compatibility with mobile devices and its cross-browser functionality. Each feature achieved a 100% validity rate in effectiveness testing. Moreover, efficiency testing revealed a task completion time of 0.156 tasks per second. User satisfaction assessments, conducted using the SUS method, yielded a score of 84, categorizing it as grade B and considered acceptable. It can be concluded that the users have successfully achieved their goals, and this application is deemed suitable.

Abstract: One of the mandatory courses for students majoring in guidance and counseling is a behavior counseling practicum. The purpose of this research is to develop the behavior counseling e-module based on case studies that can be applied to students of guidance and counseling. The research and development design used in this study is the ADDIE model. The instrument used is a module assessment scale. The assessors are experts in guidance and counseling, media, language, and prospective users. Index agreement result of the product by the guidance and counseling expert validator is 1 (very high), the media expert is 0.93 (very high), the language expert is 0.90 (very high), and the user assessment showed the mean score is 3.55 (very high in 4 scales). The developed product, e-module, has met the product acceptability criteria from various specified aspects. Abstrak: Salah satu mata kuliah wajib bagi mahasiswa jurusan bimbingan dan konseling adalah praktikum konseling perilaku. Tujuan dari penelitian ini adalah mengembangkan e-modul konseling perilaku berbasis studi kasus yang dapat diterapkan pada mahasiswa bimbingan dan konseling. Rancangan penelitian dan pengembangan yang digunakan dalam penelitian ini adalah model ADDIE. Instrumen yang digunakan adalah skala penilaian modul. Uji ahli melibatkan ahli di bidang bimbingan dan konseling, media, bahasa, dan calon pengguna. Hasil indeks produk oleh ahli bimbingan dan konseling adalah 1 (sangat tinggi), ahli media 0,93 (sangat tinggi), ahli bahasa 0,90 (sangat tinggi), dan penilaian pengguna menunjukkan skor rata-rata 3,55. (sangat tinggi dalam 4 skala). Produk yang dikembangkan, yaitu e-modul telah memenuhi kriteria keberterimaan produk dari berbagai aspek yang ditentukan.

Digital talent is crucial in the thriving Information Technology (IT) industry. Hence, numerous countries seek digital skills to stay competitive in the current era. In Indonesia, the challenge lies not in quantity but in the readiness of digital talents to enter the professional world. To address this issue, we observed the IT career readiness of fresh graduates and senior students from the Faculty of Computer Science, Universitas Brawijaya. The observation revealed that 82.9% of 70 respondents stated doubts about their career preparations in the IT domain. These doubts stemmed from perceived inadequacy in technical skills, lack of readiness in developing a curriculum vitae and facing job interviews. Given the need for career preparation in the IT domain, we address the development of a platform to assist aspiring IT talents. This study proposes a solution as an IT career preparation application designed using the Design Thinking method The proposed design was tested using the Usability Evaluation, yielding an effectiveness rate of 100% and an efficiency value of 0.08 goals/sec. Furthermore, a satisfaction test was conducted using the SUS questionnaire, resulting in a score of 94.75 (excellent).

The diversity of flora in Kalimantan influences the presence of microbe-associated with rhizosphere on their activities and functions in ecosystems. However, abiotic stress such as acidification, drought, and toxic soil residues negatively impacted soil health and plant growth in some regions of Kalimantan's soil. The rhizobacteria, as a group of the plant-growth-promoting rhizobacteria (PGPR), can colonize in the rhizosphere to produce their natural product in making phytohormone for root growth, maintaining soil aggregation and solubilizing the mineral in the soil. Those benefit of rhizobacteria is essential to investigate. However, the study of the role of rhizobacteria in Kalimantan soil interaction with the plant was unclear. Therefore, this review focused on the presence of rhizobacteria and their potency to solve abiotic problems in Kalimantan soil and the underlying mechanism rhizobacteria employs to tolerate harsh soil.

Para mitra terutama guru BK masih perlu meningkatkan keterampilan menerapkan teknik “Berbagi Kegembiraan” ala Konseling Model KIPAS. Para konselor dan guru BK sering pula dihadapkan dengan masalah konflik sosial dan di antara kolega, dengan siswa, dan siswa dan siswa selain konflik pribadi. Karena itu, ada tiga bagian target kegiatan ini yaitu: (1). Diperoleh deskripsi minat (“animo”) peserta pendidikan dan pelatihan teknik Berbagi Kegembiraan dan teknik Penyelesaian Konflik; (2). Diperoleh keterangan deskriptif mengenai kepuasan peserta pendidikan dan pelatihan; (3). Diperoleh masukan dari perantau akademik dan guru BK bagi perbaikan proses dan panduan pelatihan. Kegiatan ini dilaksanakan dalam situs lembaga pendidikan, konteks kelas hiterogen, metode pendidikan ekspositori dan diskusi, strategi pelatihan gathering, workshops dilengkapi Focused Group Discussion (FGD), modeling dan simulasi. Pengumpulan data dilakukan dengan daftar pertanyaan berupa “User Satisfaction Scale” beserta daftar isian. Dilakukan analisis deskriptif persentase. Kesimpulan: (1). Minat (“animo”) peserta pelatihan secara umum adalah sangat tinggi pada semua jenis kegiatan. (2). Deskripsi kepuasan para peserta tergolong sebagai memuaskan baik bagi para perantau akademik maupun bagi para guru BK/Konselor se-Malang Raya. (3). Masukan-masukan, baik berupa kritik, saran, pengharapan ke depan terhadap pelatihan semuanya dapat diserap dan dipertimbangkan untuk merevisi panduan pelatihan dan perbaikan prosedur pelatihan pada masa datang.

This research was conducted to understand the tension between two internal Hindu religious groups in Bali since 1984. The tension shows resistance of Balinese traditional Hindus to the Sampradaya or the spiritualist group of the Hare Krishna consciousness movement. The feud started from a hate speech on social media from both sides that leads to physical persecution. The research was conducted using a case study method, with interviews and observations at the scene and religious practices. This study found out that the conflict was rooted in different religious understandings between the Hare Krishna Gaudy Vaisnava theology and Balinese Hindu Traditional, as well as differences in acceptance of Balinese religious traditions. The contestation of the two parties escalated the feud on social media, then heated up to the closing of Hare Krishna's religious activities. The accumulation of tension was also triggered by religious activities and the appearance of Hare Krishna followers was considered to be in contrast to the Balinese traditional community, and the rite system was considered not to reflect Balinese customs. The research concludes that the institutional interaction between the two parties is deadlocked, although so far there is still a safety valve, namely Nyama Baraya, but the potential for conflict still arises. Similarity of ethnic background; dialogue intentions do not find common ground, the reintegration process is threatened with failure. A solution through dialogue is still the best step compared to resolving power or law enforcement, therefore efforts to bring the two parties together in dialogue must continue.

This paper aims to describe the development of Islamic psychology studies in Indonesia and find an epistemological framework developed by Islamic psychology experts in Indonesia. By utilizing the discourse analysis approach, this study has succeeded in showing that the development of Islamic Psychology studies in Indonesia can be said to be quite dynamic and productive. The reviewers and pioneers of discourse on Islamic Psychology, with their differing backgrounds, have sought to lay the epistemological foundation for the development of Islamic Psychology in the country. The development of Islamic psychology has been pursued through two patterns, namely idealistic patterns and pragmatic (realistic) patterns. Epistemologically, the discourse of Islamic Psychology in Indonesia is characterized by three approaches to understanding the human soul, namely the bayani approach; those with thematic interpretations, speculative philosophical-rational approaches, and a sufistic (irfani) approach that look more closely at the problem of the human soul are based on the spiritual experience of Sufism experts. The three approaches are taken to be able to understand the human soul as a whole. Departing from these three approaches, Islamic Psychology experts in Indonesia then succeeded in formulating various methods that can be taken to produce Islamic Psychology studies that are expected to answer the challenges of Muslims in Indonesia. However, the study of Islamic psychology in Indonesia tends to still be dominated by the epistemological style of bayani and irfani. The burhani approach, even though it has been used, but still tends to attempt to formulate philosophical concepts and soar. This approach has not yet been translated into empirical and applicative research methods (tajribi).

This research examines the Konseling Intensif dan Progresif yang Adaptif terhadap Struktur counseling model (KIPAS) based on Indonesia's archipelago. In English, this means Intensive and Progressive Counseling Adaptive to Structure. The model constitutes good news (Kabar gembira), data integration and Internalization (Integrasi dan internalisasi data), action planning (Perencanaan tindakan), plan actualization (Aktualisasi rencana), and celebration or certification (Selebrasi/Sertifikasi). Together, these steps form an acronym of KIPAS, a counseling model whose steps should be tested empirically to describe the users’ expectations or ratings. Data were collected using a satisfaction scale and analyzed in a descriptive percentage. The results show that the KIPAS steps are applicable, with user ratings ranging from very feasible to quite feasible.

THE EFFECTIVENESS OF MIND-MAPPING STRATEGY TO IMPROVE CREATIVE THINKING SKILLS IN STUDENT CAREER DECISION MAKING. The disruptive era in industrial revolution 4.0 is vital for students. In this era, students need creative thinking skills, especially in making career decisions. The Mind Mapping strategy is the right choice to train students' creative thinking skills. This creative thinking skills training is intended for students of Malang State High School Laboratory, class XII MIPA, IPS, IBB, and ICP. The expected goal is to increase the creative thinking skills of Malang State University High School Laboratory students in their career decision making. Based on the results of the study showed that creative thinking skills in career decision making before and after being trained with mind-mapping strategies, there was a significant increase. The Wilcoxon test results were Z = 4,644 with a significance of 0,000. That is, there are significant differences in creative thinking skills in student career decision making before and after being trained with mind-mapping strategies.

Abstract: This research aimed to find: (1) the difficulties possibly faced by subjects in managing personal construct when filling Tschudi ABC format; (2) key personal construct recognized by subjects in their present and desired positions; (3) the results of subjects’ learning culture internalization to the implementation of Tschudi ABC Model. This study used a qualitative approach with the type of Classroom Action Research, the empirical phenomenological variant. The observed subjects were determined by purposive sampling, taken from the students of Multicultural Counseling class. The research informants were determined through snowballing. The data collection was conducted via a medium participatory observation and in-depth interview. The individual analysis was employed in the form of dynamic analysis of the research subjects’ individual personality. This research found that: (1) there was a difficulty in the form of contradiction and disparity in personal construct management. According to the subjects, compromise and synchronization of thoughts and attitudes were effective in settling the self-denial and gap; (2) The tendency of the change of subjects’ key personal construct was intentional accompanied by discursive awareness versus withdrawal and stagnant. There was a change of key personal construct to the more productive and non-productive orientation; (3) The function of “good news” versus “bad news” was very strong in the internalization of subjects’ learning culture. Providing “good news” (positive feedback) gave rise to more non-formal and affective internalization of learning culture with the purpose stated consciously and obviously, as well as concrete, clear, decisive, and straightforward plans. Abstrak: Tujuan penelitian ini adalah menemukan: (1) kemungkinan kesulitan yang dihadapi oleh subjek dalam kelola konstruk pribadi ketika mengisi format ABC Tschudi; (2) konstruk pribadi kunci yang dikenali oleh para subjek dalam posisi sekarang dan posisi yang dituju; (3) hasil internalisasi budaya belajar subjek atas penerapan Model ABC Tschudi. Penelitian ini menggunakan pendekatan kualitatif tipe penelitian tindakan kelas, varian fenomenologi empirik. Subjek terteliti ditetapkan melalui teknik “purposive sampling”, para peserta kuliah dalam kelas Konseling Multibudaya. Informan penelitian ditetapkan secara snowballing. Pengumpulan data melalui observasi berpartisipasi medium dan wawancara mendalam. Digunakan unit analisis individual yaitu analisis dinamika konstruk pribadi perseorangan dari subjek penelitian. Temuan penelitian ini adalah: (1) ada kesulitan berupa pertentangan dan kesenjangan dalam kelola konstruk pribadi. Kompromi dan sinkronisasi pemikiran serta sikap merupakan cara efektif yang dinyatakan oleh subjek untuk mengatasi pertentangan dan kesenjangan dalam diri; (2) kecenderungan perubahan konstruksi pribadi kunci subjek adalah intensional disertai kesadaran diskursif versus withdrawal dan stagnan. Ada perubahan konstruk pribadi kunci ke arah yang lebih produktif dan ada yang ke arah non-produktif; (3) sangat kuat fungsi “kabar gembira” versus “bukan kabar gembira” dalam internalisasi budaya belajar subjek. Pemberian “kabar gembira” (balikan positif) menimbulkan internalisasi budaya belajar secara lebih non-formal afektif dengan tujuan yang dinyatakan secara sadar dan jelas, dan rencana tindakan yang konkret, jelas, tegas, dan lugas.

Abstract: This research and development aims to produce a cybercounseling reality website and a reality cybercounseling guidebook to improve self-disclosure for Vocational High School students which are grateful theoretically and practically. The research and development study steps are: preliminary study, product development, and product test. Product’s guidelines are tested using one group pretest-posttest design. Product test results show that cybercounseling reality website is gratefully theoretically and practically and also effectively to improve Vocational High School students’ self-disclosure. Abstrak: Penelitian dan pengembangan ini bertujuan menghasilkan website dan panduan cybercounseling realita untuk meningkatkan keterbukaan diri siswa Sekolah Menengah Kejuruan (SMK) yang berterima secara teoretis dan praktis. Rancangan penelitian ini menggunakan penelitian dan pengembangan dengan langkah: studi pendahuluan, pengembangan produk, dan uji produk. Panduan penggunaan produk diuji menggunakan one group pretest-posttest design. Hasil uji produk menunjukkan bahwa website cybercounseling realita berterima secara teoretis dan praktis serta efektif untuk meningkatkan keterbukaan diri siswa SMK. DOI: https://doi.org/10.17977/um001v3i22018p059

Abstract: This study aims to develop a training guide in emotion management skills to prevent bullying behavior. The method used is the research and development model for junior high school students. The trial subjects in this study included guidance and counseling experts, psychology experts, educational technology expert, and school counselors. Instruments used are the scale of emotion management skills for students, expert assessment instruments and counselors assessment instruments. Data from the assessment of guidance and counseling experts, psychology experts, educational technology expert, and three school counselors from three different schools in Malang showed that the developed product is acceptable and feasible to be used for the improvement of emotion management skills as a preventative effort of bullying behavior for junior high school students. Abstrak: Penelitian ini bertujuan untuk mengembangkan panduan pelatihan keterampilan mengelola emosi sebagai upaya preventif perilaku bullying siswa Sekolah Menengah Pertama (SMP). Metode yang digunakan dalam penelitian ini ialah model penelitian dan pengembangan. Subjek uji coba pada penelitian ini melibatkan ahli bimbingan dan konseling (BK), ahli psikologi, ahli teknologi pendidikan (TEP) dan konselor sekolah. Instrumen yang digunakan adalah skala keterampilan mengelola emosi untuk siswa, instrumen penilaian ahli dan instrumen penilaian konselor. Data hasil penilaian dari ahli BK, ahli psikologi, ahli TEP dan tiga konselor sekolah di tiga sekolah berbeda Kota Malang menunjukkan bahwa produk yang dikembangkan dapat diterima dan layak digunakan untuk peningkatan keterampilan mengelola emosi sebagai upaya preventif perilaku bullying siswa SMP. DOI: https://doi.org/10.17977/um001v3i12018p022

FITRI COUNSELING: JUZ QURANIC-BASED ON COUNSELING MODEL. Al-Qur’an as holly book that has scientific content can be revealed about human being with all their potencies and their differencies individual characters. The revealing scientific treasure is approached by Bayani method, Irfani, Burhani and HAQ mehod. The result shows that human has five natural (fitri) potencies, and has individual differencies, they are 30 personality types as like as quantity of Al-Qur'an juz. Developing human personality should be applied based on the character difference. Therefore, the juz qurani-based on idea and counseling model was made. The counseling model has five main stage and some specific behavior change techniques.

Abstract: This study aims to describe the junior high school students with Samin cultural background’s meaning of life of that comes from: creative values, experiential values and attitudinal values. This study follows the steps of survey types in a descriptive quantitative approach. The instruments used are developed in inventory. Data were analyzed by using descriptive analysis technique and SPSS 20.0 for Windows in order to determine the frequency, percentage, standard deviation, skewness. Results show that junior high school students with Samin cultural background was able to find the meaning of life through three sources of value, which experiential values reach the highest percentage (45%) followed by attitudinal value (29%), and the creative value (26%). In particular, these results illustrate that the fulfillment of meaning of life of junior high school students with a cultural background of Samin is in accordance with the Samin culture which prioritizes appreciation of the values of life before acting and responding to something. Abstrak: Penelitian ini bertujuan untuk mendeskripsikan meaning of life siswa sekolah menengah pertama dengan latar belakang budaya Samin yang bersumber dari: creative values, experiential values dan attitudinal values. Penelitian ini menggunakan langkah-langkah dalam pendekatan kuantitatif deskriptif jenis survei. Instrumen yang digunakan, dikembangkan dalam bentuk inventori. Teknik analisis data menggunakan analisis deskriptif untuk menentukan frekuensi, persentase, standar deviasi, skewness, dengan bantuan program SPSS 20.0 for windows. Hasil menunjukkan bahwa siswa sekolah menengah pertama dengan latar belakang budaya Samin mampu menemukan meaning of life melalui tiga sumber nilai, dengan experiential values menduduki persentase tertinggi (45%), diikuti attitudinal values (29%), dan creative values (26%). Secara khusus, hasil ini menggambarkan bahwa pemenuhan meaning of life siswa sekolah menengah pertama dengan latar belakang budaya Samin sesuai dengan budaya Samin yang mengutamakan penghayatan terhadap nilai-nilai kehidupan sebelum bertindak dan menyikapi sesuatu. Permalink/DOI: http://dx.doi.org/10.17977/um001v2i32017p097

Abstract: This research purpose to know the effectiveness of relaxation technique in behavioral group counseling to reducing academic stress at senior high school students. Research use one-group pretest-posttest design. The subject are selected 5 students based on high scores academic stress scale. Instruments used the scale academic stress was developed from various theories stress by Hans Selye (1976), Lazarus and Folkman (1984) with reliability is 0.898 and item validity > 0.3. Data were analyzed using wilcoxon signed ranks test. The analysis showed the Z count value is -2.032 with significance level of 0.042 0.3. Data dianalisis dengan uji beda wilcoxon signed ranks test. Hasil analisis menunjukkan nilai Z hitung -2,032 dengan taraf signifikansi 0.042 < 0.05 yang dapat disimpulkan bahwa teknik relaksasi efektif untuk menurunkan stres belajar siswa SMA.

Indonesian people should actively preserve Indonesian culture. A way to preserve Indonesian culture can be done by using Javanese scripts as a local content subject at elementary to middle school level. In the conventional learning method, almost all teachers teach writing Javanese manuscript with conventional instructional media by using a white board. We proposed a mobile application that can help students to learn how to write Javanese script in attractive way by using their finger. Since this application still in prototype stage, further study and analysis of the usability of this application are necessary to validate the feasibility in real implementation. Usability testing using USE questionnaire had been conducted to find out if application of Javanese script writing can be accepted by users. We give 30 questions about usability to 5 respondents that are familiar with android application. The result show that, the proposed application is acceptable to users in term of Usefulness, ease of use, ease of learning and satisfaction.

Abstract: CD19-directed chimeric antigen receptor T-cell (CAR T) therapies, including axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), and lisocabtagene maraleucel (liso-cel), have transformed the treatment landscape for B-cell non-Hodgkin lymphoma, showcasing significant efficacy but also highlighting toxicity risks such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). The US Food and Drug Administration has mandated patients remain close to the treatment center for 4 weeks as part of a Risk Evaluation and Mitigation Strategy to monitor and manage these toxicities, which, although cautious, may add to cost of care, be burdensome for patients and their families, and present challenges related to patient access and socioeconomic disparities. This retrospective study across 9 centers involving 475 patients infused with axi-cel, tisa-cel, and liso-cel from 2018 to 2023 aimed to assess CRS and ICANS onset and duration, as well as causes of nonrelapse mortality (NRM) in real-world CAR T recipients. Although differences were noted in the incidence and duration of CRS and ICANS between CAR T products, new-onset CRS and ICANS are exceedingly rare after 2 weeks after infusion (0% and 0.7% of patients, respectively). No new cases of CRS occurred after 2 weeks and a single case of new-onset ICANS occurred in the third week after infusion. NRM is driven by ICANS in the early follow-up period (1.1% until day 28) and then by infection through 3 months after infusion (1.2%). This study provides valuable insights into optimizing CAR T therapy monitoring, and our findings may provide a framework to reduce physical and financial constraints for patients., (© 2024 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)

Background: Chimeric antigen receptor T cell (CAR-T) therapy is an emerging form of immunotherapy that has recently gained recognition for treating hematological malignancies. This successful utilization of CAR-T therapy has attracted interest in its application in refractory rheumatological diseases. Here, we will review the use of CAR-T therapy in rheumatological diseases., Methods: Per PRISMA guidelines, a comprehensive literature search was performed on PubMed, Cochrane, and ClinicalTrials.gov using keywords for 'CAR-T cell therapy' and 'Rheumatological diseases' from inception to December 9, 2023. After screening 2977 articles, six studies reporting outcomes of CAR-T cell therapies in patients with underlying autoimmune /rheumatological diseases. Descriptive analysis was performed to represent demographics and clinical outcomes., Results: A total of 101 adult patients from six studies were included in this systematic review. The median age of the participants was 50.8 years (IQR: 14.875), with ages ranging from 18 to 83 years. The included studies comprised 2 case reports, 1 case series, one observational study, and two clinical trials. The studies were conducted globally, including USA, Germany, and China. The underlying rheumatologic conditions were systemic lupus erythematosus (17.8 %), rheumatoid arthritis (23.8 %), myasthenia gravis (13.8 %), neuromyelitis optica (11.9 %), and others (32.7 %). The target of CAR-T therapy included CD-19 in four studies and B cell maturation antigen (BCMA) in two studies. All the patients were on prior therapy, including glucocorticoids and disease-modifying antirheumatic drugs. Follow-up ranged from a month to 1.5 years. Most of the studies reported improvement in the symptoms and decline in serological biomarkers of the underlying disease. The notable outcomes in the included studies were a 100 % response rate in five out of six studies. Grade 1 and 2 cytokine release syndrome (CRS) was observed in five studies. Only one study reported Grade 3 or higher CRS. 2 patients (1.98 %) developed neurotoxicity among the adverse effects., Conclusion: CAR-T cell therapy is a paradigm shift in managing rheumatologic diseases, with symptomatic improvement and biochemical control of these diseases. Although preliminary evidence indicates promising results, long-term follow-up and prospective clinical trials are needed to establish optimal timing and assess the safety and efficacy of CAR-T immunotherapy., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Three critically ill, chemotherapy-refractory patients with diffuse large B-cell lymphoma (DLBCL) received loncastuximab tesirine in conjunction with standard therapies for secondary malignancy-associated hemophagocytic lymphohistiocytosis (Mal-HLH). All patients were treated inpatient, with one requiring intubation on the day of administration. Each patient had an H-score >238, indicating a >98% probability of HLH. A significant reduction in ferritin levels was observed in two patients, and one patient achieved a complete response (CR). Loncastuximab tesirine demonstrated promise in managing Mal-HLH where previous treatments had failed. This study suggests that loncastuximab tesirine exhibits favorable activity and should be considered a valuable addition to the treatment options for Mal-HLH driven by DLBCL., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Schieber et al.)

Background: We aimed to investigate factors associated with cytomegalovirus (CMV) viremia and CMV disease and its impact on post-transplant outcomes including overall survival (OS) following allogeneic hematopoietic stem cell transplantation (Allo-SCT)., Methods: We conducted a single-center retrospective study including 452 Allo-SCT recipients (matched unrelated donor, MUD 61%; haploidentical, haplo 39%) from 2016 to 2021. Data were analyzed using SPSS v28. Descriptive (chi-square and t-test), Kaplan-Meier and regression analyses were conducted., Results: The median age was 57 years. Sixty-one percent were males and 84.3% were Caucasians. CMV serostatus was positive in 59.1% of recipients. The median follow-up was 24.4 months. CMV viremia and CMV disease were observed in 181 (40%) and 32 (7%) patients, respectively. Among CMV seropositive recipients, 65% developed CMV viremia and 11% were noted to have CMV disease compared to 4% and 1% in seronegative recipients, respectively (p < 0.001). Patients with CMV disease had significantly lower OS than those without CMV disease (median 14.1 months vs. not reached, p = 0.024); however, OS was not associated with CMV viremia (median not reached in both groups, p = 0.640). Letermovir prophylaxis was used in 66% (n = 176/267) of CMV seropositive recipients, but no impact was observed on the incidence of CMV viremia or CMV disease and OS., Conclusions: CMV disease leads to significantly inferior survival after an allogeneic hematopoietic cell transplantation. Recipient CMV seropositive status was associated with the risk of CMV viremia and CMV disease, and this was not abrogated with the use of Letermovir prophylaxis., Competing Interests: Declaration of competing interest No relevant conflict of interest. SHA has speaking, consulting and advisory roles, and research funding from Incyte and Therakos. JPM has speaking, consulting and advisory role in Kite, Juno Therapeutics, Allovir, Magenta Therapeutics, EcoR1 Capital, and has research funding from Novartis, Fresenius Biotech, Astellas Pharma, Bellicum Pharmaceuticals, Gamida Cell, Pluristem Therapeutics, Kite and AlloVir. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023. Published by Elsevier B.V.)

We investigated the outcomes after adult haploidentical (haplo) and matched unrelated donor (MUD) hematopoietic cell transplantation (HCT) in a single-center study ( n  = 452) including 276 MUD and 176 haplo transplants. Myeloablative (37%) and reduced-intensity conditioning (63%) were performed. Graft sources included peripheral blood (50%) and bone marrow (50%). GVHD prophylaxis included tacrolimus/methotrexate (53%) and post-transplant cyclophosphamide-based (47%). In MUD versus haplo HCT recipients, a similar incidence of neutrophil engraftment (18 vs 17 days, p  = 0.895), grade II-IV acute GVHD (51% vs 50%, p  = 0.773), relapse (26% vs 23%, p  = 0.578), non-relapse mortality (22% vs 23%, p  = 0.817), 1-year disease-free survival (62% vs 63%. p  = 0.921), and 1-year overall survival (73% vs 74%, p  = 0.744) were observed. Earlier platelet engraftment (22 vs 27 days, p  < 0.001) and higher chronic GVHD (45% vs 35%, p  = 0.040) were noted in MUD as compared to haplo HCT. Allogeneic transplantation should be done promptly whenever indicated, utilizing either matched unrelated or haploidentical donors.

We investigated the outcomes after Coronavirus disease 2019 (COVID) in hematopoietic cell transplant (HCT) or chimeric antigen receptor-T cell (CART) therapy recipients in a single-centre study including all ( n  = 261)HCT/CART recipients (allogeneic-HCT 49%, autologous-HCT 40%, CART 11%). The median age was 60 (22-80) years. COVID severity was mild (74%), moderate (11%), and severe/critical (16%) with a mortality rate of 7% and a median duration of infection of 5.7 weeks. Significant predictors of COVID severe disease or mortality included concurrent infection (HR 14.9, 95% CI 2.2-5.6) and immunosuppressive therapy (OR 4.8, 95% CI 1.2-3.4).HCT/CART recipients have a higher risk of mortality with COVID and warrant vigilant interventions.

Background: CD19 directed CAR-T therapy for Large B-cell lymphoma (LBCL) has shown great therapeutic response in patients with relapsed/refractory disease with response rates of 60-80%. However, in patients with a partial response (PR) on initial day 28 post CAR-T therapy imaging, clinical uncertainty remains as half of these patients will ultimately have relapsed disease.   PATIENTS: In 24 patients receiving CD19 directed CAR-T therapy for relapsed/refractory LBCL achieving a PR on day 28, we utilize imaging biomarkers by 18F-FDG PET/CT imaging at pre CAR-T therapy baseline and day 28 to determine factors that may predict best overall response (B-OR), progression free survival (PFS), and overall survival (OS).   METHODS: Out of 75 patients receiving CAR-T therapy at a single institution, we retrospectively identified and reviewed 25 (33%) as achieving a PR on day 28. PR was defined using the 2014 Lugano classification system. All patients received standard of care CD19 directed CAR-T therapy with axicabtagene ciloleucel. Two independent nuclear medicine physicians measured baseline (pre-CAR-T therapy) and day 28 PET/CT SUVmax, SUVmean and TMV (cm3) of each lesion (node, organ or marrow uptake, if any) using ROVER software. All statistical tests were two-sided and conducted at the 0.05 level of significance. R version 1.3.1099 (R-studio) was used for statistical modeling.   CONCLUSION: We demonstrate that a higher day 28 SUVmax was significantly higher in those with a B-OR of PR and in our modeling, a lower day 28 SUVmax may predict favorable PFS and OS. Additionally, lower TMV, both at baseline and day 28, may also be predictive of longer PFS and OS, while lower TLG at baseline, but not day 28 is significantly associated with a B-OR of CR. While further study is warranted, these imaging biomarkers may allow for early identification of those with a day 28 PR at highest risk for relapse leading to early intervention to improve long term outcomes., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background/aims: Chimeric antigen receptor T-cell (CAR T) therapy has been shown to improve the remission rate and survival for patients with refractory haematological malignancies. The aim of this study is to describe ocular adverse effects associated with CAR T therapy in patients with haematological malignancies., Methods: This is a retrospective, single-institution, case series. Patients aged 18 years or older who received standard of care CAR T therapy for relapsed/refractory large B-cell lymphoma with a documented ophthalmic evaluation were included. The primary outcome was clinician ophthalmic examination findings., Results: A total of 66 patients received CAR T-cell therapy from February 2018 to October 2019 with 11 receiving an ophthalmic examination. Eleven patients (n=22 eyes) who received CAR T-cell therapy were included in review. The median time from CAR T-cell infusion date to ocular examination was 57.5 days. The median patient age at the time of examination was 60.5 years. Ten patients had subjective symptoms prompting ophthalmic examination. Two patients reported floaters and photopsias. One patient had worsening ocular graft-versus-host disease. Two patients were identified with possible reactivation of viral infections, including herpes zoster ophthalmicus and regressing acute retinal necrosis., Conclusions: The increasing use of CAR T therapy for malignancies underscores the importance of ophthalmologists and oncologists understanding the potential toxicities associated with its use, particularly ocular toxicities and when to refer for an ophthalmic examination., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: We conducted a systematic review and meta-analysis to evaluate outcomes following chimeric antigen receptor T cell (CAR-T) therapy in relapsed/refractory acute myeloid leukemia (RR-AML)., Methods: We performed a literature search on PubMed, Cochrane Library, and Clinicaltrials.gov. After screening 677 manuscripts, 13 studies were included. Data was extracted following PRISMA guidelines. Pooled analysis was done using the meta-package by Schwarzer et al. Proportions with 95% confidence intervals (CI) were computed., Results: We analyzed 57 patients from 10 clinical trials and 3 case reports. The pooled complete and overall response rates were 49.5% (95% CI 0.18-0.81, I 2  =65%) and 65.2% (95% CI 0.36-0.91, I 2  =57%). The pooled incidence of cytokine release syndrome, immune-effector cell associated neurotoxicity syndrome, and graft-versus-host disease was estimated as 54.4% (95% CI 0.17-0.90, I 2  =77%), 3.9% (95% CI 0.00-0.19, I 2  =22%), and 1.6% (95%CI 0.00-0.21, I 2  =33%), respectively., Conclusion: CAR-T therapy has demonstrated modest efficacy in RR-AML. Major challenges include heterogeneous disease biology, lack of a unique targetable antigen, and immune exhaustion., Competing Interests: JM has speaking, consulting and advisory role in Kite, Juno Therapeutics, Allovir, Magenta Therapeutics, EcoR1 Capital, and has research funding from Novartis, Fresenius Biotech, Astellas Pharma, Bellicum Pharmaceuticals, Gamida Cell, Pluristem Therapeutics, Kite and AlloVir. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Shahzad, Nguyen, Hussain, Ammad-Ud-Din, Faisal, Tariq, Ali, Butt, Anwar, Chaudhary, Lutfi, Ahmed, Singh, Hematti, McGuirk and Mushtaq.)

The landscape for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) has continued to evolve. However, challenges continue to exist, particularly in patients who do not respond to first-line anti-CD20 monoclonal antibody and anthracycline-based therapy or those who experience early relapse. In such patients, the treatment paradigm has changed little in the past 2 decades, with salvage chemotherapy followed by myeloablative chemotherapy and autologous hematopoietic stem cell transplant resulting in historical durable response rates of approximately 40%. Given the success of chimeric antigen receptor (CAR) T-cell therapy in the third- or later-line in the R/R LBCL setting, 3 recent clinical trials (ZUMA-7, BELINDA, and TRANSFORM) have sought to address the clinical need for improved therapies in the high-risk second-line setting for primary R/R disease in the first 12 months. In this review, we analyze these 3 pivotal trials with a focus on clinical trial design, CAR T-cell product attributes, efficacy data, safety data, and patient-reported outcomes when compared with standard of care.

We systematically evaluated the primary and secondary endpoints used in acute myeloid leukemia (AML) phase III randomized controlled trials (RCTs). We included 238 phase III AML RCTs in the past 15 years that reported 279 primary endpoints and 657 secondary endpoints. Overall survival (OS), progression-free survival (PFS), event-free survival (EFS), and complete remission (CR) were primary endpoints in 120 (43%), 34 (12%), 30 (11%), and 41 (15%) studies, respectively. OS (12.5%), PFS (13.2%), CR (14%), safety (11%), and EFS (9%) were commonly reported secondary endpoints. Among primary endpoints, a higher use of OS (OR 2.03, 95%CI 1.10-3.75, p  = 0.023) and lower use of PFS (OR 0.25, 95%CI 0.12-0.52, p  < 0.001) was observed from 2014 to 2021 compared to 2006-2013; CR was frequently used in relapsed/refractory compared to frontline RCTs (OR 2.20, 95%CI 1.11-4.38, p  = 0.025); EFS was frequently used in frontline compared to relapsed/refractory AML RCTs (OR 10.11, 95%CI 1.34-76.34, p  = 0.025). A higher trend in the use of clinically meaningful and objective endpoint of OS over the last 15 years.

Background: Reduced intensity conditioning (RIC) regimens decrease the risk for nonrelapse mortality (NRM) in adult patients undergoing allogeneic hematopoietic stem cell transplantation for hematologic malignancies but increase the risk for relapse. The aim of this study was to compare the outcomes of fludarabine-total body irradiation (TBI) with fludarabine among patients with hematologic diseases., Patients and Methods: This retrospective study of 137 patients with different hematologic malignancies compared the outcomes of 63 patients who received a conventional RIC regimen with 2 days of IV busulfan (3.2 mg/kg/d × 2 days) and fludarabine with 74 patients who received the same regimen plus 400 cGy of fludarabine and busulfan (FB)-TBI divided in 2 doses over 1 day (200 cGy BID). Median follow-up was 4.62 years., Results: The donors were either HLA-matched siblings (36%) or HLA-matched unrelated donors (64%). The FB-TBI showed trends toward improvement in progression-free survival (PFS) and overall survival (OS) over FB (5-year PFS rates 50% vs 34%, P = .06, and 5-year OS rate 53% vs 39%, P = .13). Acute graft-vs-host disease (aGVHD), relapse, and NRM were similar between the 2 groups. The 5-year cumulative incidence of chronic GVHD (cGVHD) was lower in the FB-TBI group compared with the FB group (29% vs 52%, P = .003). Multivariable analysis revealed that grade III-IV aGVHD was the only independent risk factor for worse OS (P = .001) in both groups. A high disease risk index was possibly associated with inferior OS (P = .07) in both groups., Conclusions: The FB-TBI is a safe and effective intensified RIC regimen for adult patients with hematologic malignancies. It predicted a lower risk for cGVHD and showed possibly improved PFS and OS compared with FB., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Secondary hemophagocytic lymphohistiocytosis (HLH) is a life-threatening immune dysregulation disorder. Use of chimeric antigen receptor T-cell therapy (CAR-T) is associated with cytokine release syndrome (CRS), Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS) and secondary HLH. However, application of HLH scoring systems (H-score, HLH-2004 criteria) are not validated in this setting. We analyzed the utility of applying the H-score and the HLH-2004 criteria to identify patients with possible HLH post-CAR-T for Relapsed/Refractory Diffuse Large B-cell Lymphoma. Only two of four patients with post CAR-T HLH met five or more of the diagnostic criteria for HLH by HLH 2004 criteria. In contrast all four post CAR-T HLH patients had a high H-score (>169); however, an additional ten patients that did not have HLH also had a high H-score. Thus, in this patient population, both scoring systems were demonstrated to have low prognostic significance in differentiating between high grade CRS and HLH.

In light of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) variants potentially undermining humoral immunity, it is important to understand the fine specificity of the antiviral antibodies. We screened 20 COVID-19 patients for antibodies against 9 different SARS-CoV-2 proteins observing responses against the spike (S) proteins, the receptor-binding domain (RBD), and the nucleocapsid (N) protein which were of the IgG1 and IgG3 subtypes. Importantly, mutations which typically occur in the B.1.351 "South African" variant, significantly reduced the binding of anti-RBD antibodies. Nine of 20 patients were critically ill and were considered high-risk (HR). These patients showed significantly higher levels of transforming growth factor beta (TGF-β) and myeloid-derived suppressor cells (MDSC), and lower levels of CD4 + T cells expressing LAG-3 compared to standard-risk (SR) patients. HR patients evidenced significantly higher anti-S1/RBD IgG antibody levels and an increased neutralizing activity. Importantly, a large proportion of S protein-specific antibodies were glycosylation-dependent and we identified a number of immunodominant linear epitopes within the S1 and N proteins. Findings derived from this study will not only help us to identify the most relevant component of the anti-SARS-CoV-2 humoral immune response but will also enable us to design more meaningful immunomonitoring methods for anti-COVID-19 vaccines., (© 2021. The Author(s).)

In the relapsed/refractory setting for treatment of large B-cell lymphoma (LBCL), chimeric antigen receptor T-cell (CAR-T) therapy has emerged as an effective treatment modality. Patients often have aggressive disease that requires prompt treatment in the form of bridging therapy (BT) for disease stabilisation while CAR-T cells are manufactured. Patients (n = 75) undergoing CAR-T therapy infusion for LBCL at our institution were identified. A total of 52 (69·3%) received BT and 23 (30·7%) received no BT (NBT). BT modalities included systemic BT (SBT) in 28 patients, radiation BT (RBT) in 14, and high-dose steroid BT (HDS) in 10. There was no difference in incidence of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome between BT and NBT (P = 0·18 and P = 0·53 respectively). Prolonged cytopenias at Day 180 were more common in BT than NBT (50% vs. 13·3%, P = 0·04). The SBT and RBT subgroups had more cytopenias at Day 180 compared to the HDS and NBT subgroups (58·3% and 57·1% vs. 20% and 13·3% respectively, P = 0·04). Disease response at last follow-up, progression-free survival and overall survival were similar between BT, NBT, and BT subgroups. In summary, BT can be safely considered in patients undergoing CAR-T therapy. However, those undergoing BT with SBT or RBT are at higher risk of prolonged cytopenias after CAR-T therapy., (© 2021 British Society for Haematology and John Wiley & Sons Ltd.)

Immune checkpoint inhibitor therapies and allogeneic hematopoietic cell transplant (alloHCT) represent two distinct modalities that offer a chance for long-term cure in a diverse array of malignancies and have experienced many breakthroughs in recent years. Herein, we review the CD27-CD70 co-stimulatory pathway and its therapeutic potential in 1) combination with checkpoint inhibitor and other immune therapies and 2) its potential ability to serve as a novel approach in graft- versus -host disease (GVHD) prevention. We further review recent advances in the understanding of GVHD as a complex immune phenomenon between donor and host immune systems, particularly in the early stages with mixed chimerism, and potential novel therapeutic approaches to prevent the development of GVHD., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Lutfi, Wu, Sunshine and Cao.)

Background: CD19-directed chimeric antigen receptor (CAR) T-cell therapy (CAR-T) has emerged as effective for relapsed/refractory large B-cell lymphoma (R/R LBCL). The neurologic toxicity seen with CAR-T, referred to as immune effector cell-associated neurotoxicity syndrome (ICANS), is poorly understood. To better elucidate the clinical characteristics, treatment outcomes, and correlative biomarkers of ICANS, we review here a single-center analysis of ICANS after CAR T-cell therapy in R/R LBCL., Methods: Patients (n = 45) with R/R LBCL treated with axicabtagene ciloleucel (axi-cel) were identified. Data regarding treatment course, clinical outcomes, and correlative studies were collected. Patients were monitored and graded for ICANS via CARTOX-10 scoring and Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria, respectively., Results: Twenty-five (56%) patients developed ICANS, 18 (72%) of whom had severe (CTCAE grades 3-4) ICANS. Median time to development of ICANS was 5 days (range, 3-11). Elevated pre-infusion (day 0 [D0]) fibrinogen (517 vs 403 mg/dL, upper limit of normal [ULN] 438 mg/dL, P = 0.01) and D0 lactate dehydrogenase (618 vs 506 units/L, ULN 618 units/L, P = 0.04) were associated with ICANS. A larger drop in fibrinogen was associated with ICANS (393 vs 200, P < 0.01). Development of ICANS of any grade had no effect on complete remission (CR), progression-free survival (PFS), or overall survival (OS). Duration and total dose of steroid treatment administered for ICANS did not influence CR, PFS, or OS., Conclusions: ICANS after CAR-T with axi-cel for R/R LBCL was seen in about half of patients, the majority of which were high grade. Contrary to previous reports, neither development of ICANS nor its treatment were associated with inferior CR, PFS, or OS. The novel finding of high D0 fibrinogen level can identify patients at higher risk for ICANS., (© The Author(s) 2020. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)