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3. NUDT15 variants confer high incidence of second malignancies in children with acute lymphoblastic leukemia

Author

Yoshida, Masanori, Nakabayashi, Kazuhiko, Yang, Wentao, Sato-Otsubo, Aiko, Tsujimoto, Shin-ichi, Ogata-Kawata, Hiroko, Kawai, Tomoko, Ishiwata, Keisuke, Sakamoto, Mika, Okamura, Kohji, Yoshida, Kaoru, Shirai, Ryota, Osumi, Tomoo, Moriyama, Takaya, Nishii, Rina, Takahashi, Hiroyuki, Kiyotani, Chikako, Shioda, Yoko, Terashima, Keita, Ishimaru, Sae, Yuza, Yuki, Takagi, Masatoshi, Arakawa, Yuki, Kinoshita, Akitoshi, Hino, Moeko, Imamura, Toshihiko, Hasegawa, Daisuke, Nakazawa, Yozo, Okuya, Mayuko, Kakuda, Harumi, Takasugi, Nao, Inoue, Akiko, Ohki, Kentaro, Yoshioka, Takako, Ito, Shuichi, Tomizawa, Daisuke, Koh, Katsuyoshi, Matsumoto, Kimikazu, Sanada, Masashi, Kiyokawa, Nobutaka, Ohara, Akira, Ogawa, Seishi, Manabe, Atsushi, Niwa, Akira, Hata, Kenichiro, Yang, Jun J., and Kato, Motohiro

Published
2021
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4. Prognostic value of the revised International Prognostic Scoring System five-group cytogenetic abnormality classification for the outcome prediction of hematopoietic stem cell transplantation in pediatric myelodysplastic syndrome

Author

Yamamoto, Shohei, Kato, Motohiro, Watanabe, Kenichiro, Ishimaru, Sae, Hasegawa, Daisuke, Noguchi, Maiko, Hama, Asahito, Sato, Maho, Koike, Takashi, Iwasaki, Fuminori, Yagasaki, Hiroshi, Takahashi, Yoshiyuki, Kosaka, Yoshiyuki, Hashii, Yoshiko, Morimoto, Akira, Atsuta, Yoshiko, Hasegawa, Daiichiro, and Yoshida, Nao

Published
2021
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5. Hematopoietic stem cell transplantation for infants with high-risk KMT2A gene–rearranged acute lymphoblastic leukemia

Author

Takachi, Takayuki, Watanabe, Tomoyuki, Miyamura, Takako, Moriya Saito, Akiko, Deguchi, Takao, Hori, Toshinori, Yamada, Tomomi, Ohmori, Shigeru, Haba, Masami, Aoki, Yuki, Ishimaru, Sae, Sasaki, Shinya, Ohshima, Junjiro, Iguchi, Akihiro, Takahashi, Yoshiyuki, Hyakuna, Nobuyuki, Manabe, Atsushi, Horibe, Keizo, Ishii, Eiichi, Koh, Katsuyoshi, and Tomizawa, Daisuke

Published
2021
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6. The PedAL/EuPAL Project:A Global Initiative to Address the Unmet Medical Needs of Pediatric Patients with Relapsed or Refractory Acute Myeloid Leukemia

Author

Ceolin, Valeria, Ishimaru, Sae, Karol, Seth E., Bautista, Francisco, Goemans, Bianca Frederika, Gueguen, Gwenaëlle, Willemse, Marieke, Di Laurenzio, Laura, Lukin, Jennifer, van Tinteren, Harm, Locatelli, Franco, Petit, Arnaud, Tomizawa, Daisuke, Norton, Alice, Kaspers, Gertjan, Reinhardt, Dirk, Tasian, Sarah K., Nichols, Gwen, Kolb, Edward Anders, Zwaan, Christian Michel, Cooper, Todd Michael, Ceolin, Valeria, Ishimaru, Sae, Karol, Seth E., Bautista, Francisco, Goemans, Bianca Frederika, Gueguen, Gwenaëlle, Willemse, Marieke, Di Laurenzio, Laura, Lukin, Jennifer, van Tinteren, Harm, Locatelli, Franco, Petit, Arnaud, Tomizawa, Daisuke, Norton, Alice, Kaspers, Gertjan, Reinhardt, Dirk, Tasian, Sarah K., Nichols, Gwen, Kolb, Edward Anders, Zwaan, Christian Michel, and Cooper, Todd Michael

Abstract

The prognosis of children with acute myeloid leukemia (AML) has improved incrementally over the last few decades. However, at relapse, overall survival (OS) is approximately 40–50% and is even lower for patients with chemo-refractory disease. Effective and less toxic therapies are urgently needed for these children. The Pediatric Acute Leukemia (PedAL) program is a strategic global initiative that aims to overcome the obstacles in treating children with relapsed/refractory acute leukemia and is supported by the Leukemia and Lymphoma Society in collaboration with the Children’s Oncology Group, the Innovative Therapies for Children with Cancer consortium, and the European Pediatric Acute Leukemia (EuPAL) foundation, amongst others. In Europe, the study is set up as a complex clinical trial with a stratification approach to allocate patients to sub-trials of targeted inhibitors at relapse and employing harmonized response and safety definitions across sub-trials. The PedAL/EuPAL international collaboration aims to determine new standards of care for AML in a first and second relapse, using biology-based selection markers for treatment stratification, and deliver essential data to move drugs to front-line pediatric AML studies. An overview of potential treatment targets in pediatric AML, focused on drugs that are planned to be included in the PedAL/EuPAL project, is provided in this manuscript.

Published
2024

7. The PedAL/EuPAL Project: A Global Initiative to Address the Unmet Medical Needs of Pediatric Patients with Relapsed or Refractory Acute Myeloid Leukemia

Author

Ceolin, Valeria, primary, Ishimaru, Sae, additional, Karol, Seth E., additional, Bautista, Francisco, additional, Goemans, Bianca Frederika, additional, Gueguen, Gwenaëlle, additional, Willemse, Marieke, additional, Di Laurenzio, Laura, additional, Lukin, Jennifer, additional, van Tinteren, Harm, additional, Locatelli, Franco, additional, Petit, Arnaud, additional, Tomizawa, Daisuke, additional, Norton, Alice, additional, Kaspers, Gertjan, additional, Reinhardt, Dirk, additional, Tasian, Sarah K., additional, Nichols, Gwen, additional, Kolb, Edward Anders, additional, Zwaan, Christian Michel, additional, and Cooper, Todd Michael, additional

Published
2023
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11. The PedAL/EuPAL Project: A Global Initiative to Address the Unmet Medical Needs of Pediatric Patients with Relapsed or Refractory Acute Myeloid Leukemia.

Author

Ceolin, Valeria, Ishimaru, Sae, Karol, Seth E., Bautista, Francisco, Goemans, Bianca Frederika, Gueguen, Gwenaëlle, Willemse, Marieke, Di Laurenzio, Laura, Lukin, Jennifer, van Tinteren, Harm, Locatelli, Franco, Petit, Arnaud, Tomizawa, Daisuke, Norton, Alice, Kaspers, Gertjan, Reinhardt, Dirk, Tasian, Sarah K., Nichols, Gwen, Kolb, Edward Anders, and Zwaan, Christian Michel

Subjects
*BIOMARKERS, *REPORTING of diseases, *DRUG efficacy, *CLINICAL trials, *PEDIATRICS, *PROGNOSIS, *DISEASE relapse, *LYMPHOMAS, *NEEDS assessment, *MEDICAL needs assessment, *PATIENT safety
Abstract

Simple Summary: The prognosis of children with relapsed/refractory (R/R) acute myeloid leukemia (AML) remains poor, and innovative treatments are needed. Most drugs approved for adults with AML over the last decade are not available or not licensed for use in children. Clinical trials in pediatric AML to assess the safety and/or efficacy of new drugs may take a long time to recruit given smaller patient numbers. The overarching aim of the Pediatric Acute Leukemia (PedAL) program, supported by the Leukemia and Lymphoma Society as part of its Dare to Dream Project, is to establish new standards of care for children with R/R AML via international collaboration in Europe, North America, and Asia-Pacific to accelerate clinical trial conduction, increase access to promising new therapies, and create a registry of uniformly-collected data. These efforts will facilitate biomarker-driven approaches of targeted therapies, of which an overview is provided in this manuscript, with the intent to obtain regulatory approvals. The prognosis of children with acute myeloid leukemia (AML) has improved incrementally over the last few decades. However, at relapse, overall survival (OS) is approximately 40–50% and is even lower for patients with chemo-refractory disease. Effective and less toxic therapies are urgently needed for these children. The Pediatric Acute Leukemia (PedAL) program is a strategic global initiative that aims to overcome the obstacles in treating children with relapsed/refractory acute leukemia and is supported by the Leukemia and Lymphoma Society in collaboration with the Children's Oncology Group, the Innovative Therapies for Children with Cancer consortium, and the European Pediatric Acute Leukemia (EuPAL) foundation, amongst others. In Europe, the study is set up as a complex clinical trial with a stratification approach to allocate patients to sub-trials of targeted inhibitors at relapse and employing harmonized response and safety definitions across sub-trials. The PedAL/EuPAL international collaboration aims to determine new standards of care for AML in a first and second relapse, using biology-based selection markers for treatment stratification, and deliver essential data to move drugs to front-line pediatric AML studies. An overview of potential treatment targets in pediatric AML, focused on drugs that are planned to be included in the PedAL/EuPAL project, is provided in this manuscript. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Prevalence of pathogenic variants in cancer‐predisposing genes in second cancer after childhood solid cancers

Author

Yoshida, Masanori, primary, Nakabayashi, Kazuhiko, additional, Yang, Wentao, additional, Sato‐Otsubo, Aiko, additional, Tsujimoto, Shin‐ichi, additional, Ogata‐Kawata, Hiroko, additional, Kawai, Tomoko, additional, Ishiwata, Keisuke, additional, Sakamoto, Mika, additional, Okamura, Kohji, additional, Yoshida, Kaoru, additional, Shirai, Ryota, additional, Osumi, Tomoo, additional, Kiyotani, Chikako, additional, Shioda, Yoko, additional, Terashima, Keita, additional, Ishimaru, Sae, additional, Yuza, Yuki, additional, Takagi, Masatoshi, additional, Arakawa, Yuki, additional, Imamura, Toshihiko, additional, Hasegawa, Daisuke, additional, Inoue, Akiko, additional, Yoshioka, Takako, additional, Ito, Shuichi, additional, Tomizawa, Daisuke, additional, Koh, Katsuyoshi, additional, Matsumoto, Kimikazu, additional, Kiyokawa, Nobutaka, additional, Ogawa, Seishi, additional, Manabe, Atsushi, additional, Niwa, Akira, additional, Hata, Kenichiro, additional, Yang, Jun J., additional, and Kato, Motohiro, additional

Published
2023
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13. Prognostic value of the revised International Prognostic Scoring System five-group cytogenetic abnormality classification for the outcome prediction of hematopoietic stem cell transplantation in pediatric myelodysplastic syndrome

Author

Yamamoto, Shohei, Kato, Motohiro, Watanabe, Kenichiro, Ishimaru, Sae, Hasegawa, Daisuke, Noguchi, Maiko, Hama, Asahito, Sato, Maho, Koike, Takashi, Iwasaki, Fuminori, Yagasaki, Hiroshi, Takahashi, Yoshiyuki, Kosaka, Yoshiyuki, Hashii, Yoshiko, Morimoto, Akira, Atsuta, Yoshiko, Hasegawa, Daiichiro, and Yoshida, Nao

Abstract

Cytogenetic abnormalities are a major risk factor for relapse after hematopoietic stem cell transplantation (HSCT) for myelodysplastic syndrome (MDS). We aimed to evaluate the value of the five-group cytogenetic classification according to the revised International Prognostic Scoring System (R-IPSS) for predicting the outcome after HSCT in pediatric patients with MDS. We retrospectively analyzed the Japanese registration data of 242 pediatric patients with MDS. According to the R-IPSS classification, 112 (45.5%) patients had good, 55 (22.7%) had intermediate, 64 (26.4%) had poor, and 11 (4.6%) had very poor cytogenetics. The 5-year overall survival (5yOS) was 72%, 69%, 59%, and 30% in the good, intermediate, poor, and very poor cytogenetic subgroups (p= 0.026), respectively. The very good, good, and intermediate subgroups were grouped into a “standard” subgroup and reclassified into three subgroups (standard, poor, and very poor). Patients with very poor risk had worse 5yOS (hazard ratio 2.17, 95% confidence interval (CI) 1.02–4.61; p= 0.04) and a much higher 5yCIR (hazard ratio 2.52, 95% CI 1.05–6.04; p= 0.04) than those of patients in the standard group in the multivariate analysis, indicating that very poor risk cytogenetic characteristics independently predicted worse outcome after HSCT in pediatric patients with MDS.

Published
2024
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14. ITCC-101/APAL2020D: A Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamycin with or without Venetoclax in Children with Relapsed Acute Myeloid Leukemia

Author

Ishimaru, Sae, primary, Gueguen, Gwenaëlle, additional, Karol, Seth E., additional, Bautista Sirvent, Francisco J., additional, Ceolin, Valeria, additional, Goemans, Bianca F., additional, Bakker, Marlous, additional, Laurenzio, Laura Di, additional, Lukin, Jennifer, additional, Van Tinteren, Harm, additional, Sunkersett, Gauri B., additional, Onishi, Maika, additional, Unnebrink, Kristina, additional, Reinhardt, Dirk, additional, Nichols, Gwen L, additional, Kolb, E. Anders, additional, and Zwaan, C. Michel, additional

Published
2022
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16. Prognostic factors of children and adolescents with T‐cell acute lymphoblastic leukemia after allogeneic transplantation

Author

Ishida, Hisashi, primary, Kato, Motohiro, additional, Kawahara, Yuta, additional, Ishimaru, Sae, additional, Najima, Yuho, additional, Kako, Shinichi, additional, Sato, Maho, additional, Hiwatari, Mitsuteru, additional, Noguchi, Maiko, additional, Kato, Keisuke, additional, Koh, Katsuyoshi, additional, Okada, Keiko, additional, Iwasaki, Fuminori, additional, Kobayashi, Ryoji, additional, Igarashi, Shunji, additional, Saito, Shoji, additional, Takahashi, Yoshiyuki, additional, Sato, Atsushi, additional, Tanaka, Junji, additional, Hashii, Yoshiko, additional, Atsuta, Yoshiko, additional, Sakaguchi, Hirotoshi, additional, and Imamura, Toshihiko, additional

Published
2022
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18. Intensification of Early-Phase Therapy to Diminish the Prognostic Effect of Myeloid Antigen Expression in Infants with KMT2A-Rearranged Acute Lymphoblastic Leukemia: A Report from the JPLSG MLL-10 Trial

Author

Arakawa, Yuki, primary, Ishihara, Takashi, additional, Miyamura, Takako, additional, Deguchi, Takao, additional, Sanada, Masashi, additional, Hori, Toshinori, additional, Yamada, Tomomi, additional, Aoki, Yuki, additional, Ishimaru, Sae, additional, Takachi, Takayuki, additional, Yano, Mio, additional, Sasaki, Shinya, additional, Saito, Akiko M, additional, Manabe, Atsushi, additional, Horibe, Keizo, additional, Imamura, Toshihiko, additional, and Tomizawa, Daisuke, additional

Published
2021
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19. Chip-AML22 Master Protocol: An Open-Label Clinical Trial in Newly Diagnosed Pediatric De Novo Acute Myeloid Leukemia (AML) Patients Including a Linked Phase II Trial with Quizartinib in FLT3-ITD/ NPM1wt Patients - a Study By the NOPHO-DB-SHIP Consortium

Author

Kaspers, Gertjan J.L., Wijnen, Noa E., Koedijk, Joost B., Ishimaru, Sae, Benedictus, Renske, Van Opstal, Ellen C., Van Tinteren, Harm, Zwaan, C. Michel, Biserna, Noha, Downs, Pamela, Duong, Yvonne, Kamel, Yasser Mostafa, Abrahamsson, Jonas, Arad-Cohen, Nira, Bodmer, Nicole, Castillo, Luis, Cheuk, Daniel, Costa, Vitor, De Moerloose, Barbara, Fernandez Navarro, Jose Maria, Fogelstrand, Linda, Goemans, Bianca F., Hasle, Henrik, Jonsson, Olafur G., Kovalova, Zhanna, Munthe-Kaas, Monica C., Norén-Nyström, Ulrika, Palmu, Sauli, Pasauliene, Ramune, Saks, Kadri, Tierens, Anne Maria, Turkiewicz, Dominik, and Pronk, Cornelis Jan

Published
2023
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20. Nationwide study of pediatric B‐cell precursor acute lymphoblastic leukemia with chromosome 8q24/ MYC rearrangement in Japan

Author

Sakaguchi, Kimiyoshi, primary, Imamura, Toshihiko, additional, Ishimaru, Sae, additional, Imai, Chihaya, additional, Shimonodan, Hidemi, additional, Fujita, Naoto, additional, Okada, Keiko, additional, Taketani, Takeshi, additional, Kanai, Rie, additional, Tauchi, Hisamichi, additional, Kato, Motohiro, additional, Kojima, Yasuko, additional, Watanabe, Arata, additional, Deguchi, Takao, additional, Hashii, Yoshiko, additional, Kiyokawa, Nobutaka, additional, Taki, Tomohiko, additional, Saito, Akiko M., additional, Horibe, Keizo, additional, Manabe, Atsushi, additional, Sato, Atsushi, additional, and Koh, Katsuyoshi, additional

Published
2020
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21. Nationwide study of pediatric B-cell precursor acute lymphoblastic leukemia with chromosome 8q24/MYC rearrangement in Japan

Author

Sakaguchi, Kimiyoshi, Imamura, Toshihiko, Ishimaru, Sae, Imai, Chihaya, Shimonodan, Hidemi, Fujita, Naoto, Okada, Keiko, Taketani, Takeshi, Kanai, Rie, Tauchi, Hisamichi, Kato, Motohiro, Kojima, Yasuko, Watanabe, Arata, Deguchi, Takao, Hashii, Yoshiko, Kiyokawa, Nobutaka, Taki, Tomohiko, Saito, Akiko M., Horibe, Keizo, Manabe, Atsushi, Sato, Atsushi, Koh, Katsuyoshi, Sakaguchi, Kimiyoshi, Imamura, Toshihiko, Ishimaru, Sae, Imai, Chihaya, Shimonodan, Hidemi, Fujita, Naoto, Okada, Keiko, Taketani, Takeshi, Kanai, Rie, Tauchi, Hisamichi, Kato, Motohiro, Kojima, Yasuko, Watanabe, Arata, Deguchi, Takao, Hashii, Yoshiko, Kiyokawa, Nobutaka, Taki, Tomohiko, Saito, Akiko M., Horibe, Keizo, Manabe, Atsushi, Sato, Atsushi, and Koh, Katsuyoshi

Abstract

BackgroundRearrangements of chromosome 8q24/MYC (8q24/MYC-r), resulting from t(8;14)(q24;q32), t(2;8)(p11;q24), or t(8;22)(q24;q11), are mainly associated with Burkitt lymphoma/leukemia (BL) and rarely observed in patients with B-cell precursor acute lymphoblastic leukemia (BCP-ALL). The characteristics of BCP-ALL with 8q24/MYC-r are poorly understood.ProcedureA retrospective nationwide study of data from patients with pediatric BCP-ALL with 8q24/MYC-r in Japan was conducted to clarify the clinical and biological characteristics associated with 8q24/MYC-r BCP-ALL.ResultsTen patients with BCP-ALL with 8q24/MYC-r, including three with double-hit leukemia (DHL) (two with t(8;14)(q24;q32) and t(14;18)(q32;q21), and one with t(8;14) and t(3;22)(q27;q11)), were identified. Patients with BCP-ALL with 8q24/MYC-r had higher median age, and uric acid (UA) and lactate dehydrogenase (LDH) levels, than those without 8q24/MYC-r. All patients were initially treated with ALL-type chemotherapy; however, four, including one with DHL, were switched to BL-type chemotherapy, based on cytogenetic findings. One patient relapsed after standard-risk ALL-type chemotherapy, and two patients with DHL did not attain complete remission with chemotherapy; all three died within 11 months. The other seven patients treated with BL-type or high-risk ALL type chemotherapy are alive without disease.ConclusionsThe clinical and laboratory features of BL with IG-MYC rearrangement, displaying a BCP immunophenotype (Wagener et al. and Herbrueggen et al. termed it as preBLL), are similar to those of BCP-ALL with 8q24/MYC-r. Low-risk ALL-type chemotherapy may not be appropriate for them, and further studies are required to establish an adequate therapeutic strategy. Further studies of DHL to identify new treatment strategies are also needed.

Published
2020

22. Nationwide survey of pediatric hypodiploid acute lymphoblastic leukemia in Japan

Author

Ishimaru, Sae, primary, Okamoto, Yasuhiro, additional, Imai, Chihaya, additional, Sakaguchi, Hirotoshi, additional, Taki, Tomohiko, additional, Hasegawa, Daisuke, additional, Cho, Yuko, additional, Kakuda, Harumi, additional, Sano, Hideki, additional, Manabe, Atsushi, additional, Imamura, Toshihiko, additional, Kato, Motohiro, additional, Arakawa, Yuki, additional, Shimonodan, Hidemi, additional, Sato, Atsushi, additional, Suenobu, Souichi, additional, Inukai, Takeshi, additional, Watanabe, Arata, additional, Kawano, Yoshifumi, additional, Kikuta, Atsushi, additional, Horibe, Keizo, additional, Ohara, Akira, additional, and Koh, Katsuyoshi, additional

Published
2019
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23. Evaluation of aprepitant and fosaprepitant in pediatric patients

Author

Saito, Yoshimasa, primary, Kumamoto, Tadashi, additional, Arima, Takamichi, additional, Shirakawa, Nami, additional, Ishimaru, Sae, additional, Sonoda, Tomoko, additional, Nakajima, Miho, additional, Sugiyama, Masanaka, additional, Arakawa, Ayumu, additional, Hashimoto, Hironobu, additional, Makino, Yoshinori, additional, Ogawa, Chitose, additional, and Yamaguchi, Masakazu, additional

Published
2019
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24. NUDT15variants confer high incidence of second malignancies in children with acute lymphoblastic leukemia

Author

Yoshida, Masanori, Nakabayashi, Kazuhiko, Yang, Wentao, Sato-Otsubo, Aiko, Tsujimoto, Shin-ichi, Ogata-Kawata, Hiroko, Kawai, Tomoko, Ishiwata, Keisuke, Sakamoto, Mika, Okamura, Kohji, Yoshida, Kaoru, Shirai, Ryota, Osumi, Tomoo, Moriyama, Takaya, Nishii, Rina, Takahashi, Hiroyuki, Kiyotani, Chikako, Shioda, Yoko, Terashima, Keita, Ishimaru, Sae, Yuza, Yuki, Takagi, Masatoshi, Arakawa, Yuki, Kinoshita, Akitoshi, Hino, Moeko, Imamura, Toshihiko, Hasegawa, Daisuke, Nakazawa, Yozo, Okuya, Mayuko, Kakuda, Harumi, Takasugi, Nao, Inoue, Akiko, Ohki, Kentaro, Yoshioka, Takako, Ito, Shuichi, Tomizawa, Daisuke, Koh, Katsuyoshi, Matsumoto, Kimikazu, Sanada, Masashi, Kiyokawa, Nobutaka, Ohara, Akira, Ogawa, Seishi, Manabe, Atsushi, Niwa, Akira, Hata, Kenichiro, Yang, Jun J., and Kato, Motohiro

Abstract

The effect of genetic variation on second malignant neoplasms (SMNs) remains unclear. First, we identified the pathogenic germline variants in cancer-predisposing genes among 15 children with SMNs after childhood leukemia/lymphoma using whole-exome sequencing. Because the prevalence was low, we focused on the association between SMNs and NUDT15in primary acute lymphoblastic leukemia (ALL) cases. NUDT15is one of the 6-mercaptopurine (6-MP) metabolic genes, and its variants are common in East Asian individuals. The prevalence of NUDT15hypomorphic variants was higher in patients with SMNs (n = 14; 42.9%) than in the general population in the gnomAD database (19.7%; P= .042). In the validation study with a cohort of 438 unselected patients with ALL, the cumulative incidence of SMNs was significantly higher among those with (3.0%; 95% confidence interval [CI], 0.6% to 9.4%) than among those without NUDT15variants (0.3%; 95% CI, 0.0% to 1.5%; P= .045). The 6-MP dose administered to patients with ALL with a NUDT15variant was higher than that given to those without SMNs (P= .045). The 6-MP–related mutational signature was observed in SMN specimens after 6-MP exposure. In cells exposed to 6-MP, a higher level of 6-MP induced DNA damage in NUDT15-knockdown induced pluripotent stem cells. Our study indicates that NUDT15variants may confer a risk of SMNs after treatment with 6-MP in patients with ALL.

Published
2021
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25. Hematopoietic stem cell transplantation for infants with high-risk KMT2Agene–rearranged acute lymphoblastic leukemia

Author

Takachi, Takayuki, Watanabe, Tomoyuki, Miyamura, Takako, Moriya Saito, Akiko, Deguchi, Takao, Hori, Toshinori, Yamada, Tomomi, Ohmori, Shigeru, Haba, Masami, Aoki, Yuki, Ishimaru, Sae, Sasaki, Shinya, Ohshima, Junjiro, Iguchi, Akihiro, Takahashi, Yoshiyuki, Hyakuna, Nobuyuki, Manabe, Atsushi, Horibe, Keizo, Ishii, Eiichi, Koh, Katsuyoshi, and Tomizawa, Daisuke

Abstract

The role of allogeneic hematopoietic stem cell transplantation (HSCT) for infants with acute lymphoblastic leukemia (ALL) and KMT2Agene rearrangement (KMT2A-r) is controversial in terms of both its efficacy and potential for acute and late toxicities. In Japanese Pediatric Leukemia/Lymphoma Study Group trial MLL-10, by introducing intensive chemotherapy, indication of HSCT was restricted to patients with high-risk (HR) features only (KMT2A-r and either age <180 days or presence of central nervous system leukemia). Of the 56 HR patients, 49 achieved complete remission. Forty-three patients received HSCT in first remission including 38 patients receiving protocol-specified HSCT with conditioning consisting of individualized targeted doses of busulfan, etoposide, and cyclophosphamide. Three-year event-free survival (EFS) of 56.8% (95% confidence interval [CI], 42.4% to 68.8%) and overall survival of 80.2% (95% CI, 67.1% to 88.5%) were accomplished. Univariable analysis showed that Interfant-HR criteria and flow cytometric minimal residual disease (MRD; ≥0.01%), both at the end of induction and at the end of consolidation (EOC), were significantly associated with poorer EFS. In the multivariable analysis, positive MRD at EOC was solely associated with poor EFS (P< .001). Rapid pretransplant MRD clearance and tailored HSCT strategy in the MLL-10 trial resulted in a favorable outcome for infants with HR KMT2A-r ALL. However, considering the high rate of potentially life-threatening toxicities and the risk of late effects, its indication should be further restricted or even eliminated in the future by introducing more effective therapeutic modalities with minimal toxicities. This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) as #UMIN000004801.

Published
2021
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26. A case of recurrent histiocytic sarcoma with MAP2K1 pathogenic variant treated with the MEK inhibitor trametinib

Author

Kumamoto, Tadashi, primary, Aoki, Yuki, additional, Sonoda, Tomoko, additional, Yamanishi, Miho, additional, Arakawa, Ayumu, additional, Sugiyama, Masanaka, additional, Shirakawa, Nami, additional, Ishimaru, Sae, additional, Saito, Yoshimasa, additional, Maeshima, Akiko, additional, Maeda, Miho, additional, and Ogawa, Chitose, additional

Published
2018
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28. The Association Between L-Asparaginase Hypersensitivity and Genetic Variants in Japanese Childhood ALL Patients

Author

Tanaka, Yoichi, primary, Urayama, Kevin Y, additional, Kawaguchi, Takahisa, additional, Mori, Makiko, additional, Hasegawa, Daisuke, additional, Ishimaru, Sae, additional, Taneyama, Yuichi, additional, Terada, Kazuki, additional, Yanagimachi, Masakatsu, additional, Ota, Setsuo, additional, Takahashi, Hiroyuki, additional, Inukai, Takeshi, additional, Toyama, Daisuke, additional, Keino, Dai, additional, Moriwaki, Koichi, additional, Takagi, Masatoshi, additional, Fujimura, Junya, additional, Sekinaka, Yujin, additional, Nakamura, Kozue, additional, Sato, Yuya, additional, Matsuo, Keitaro, additional, Ohara, Akira, additional, Koh, Katsuyoshi, additional, Matsuda, Fumihiko, additional, and Manabe, Atsushi, additional

Published
2016
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31. Long-term outcome of six months maintenance chemotherapy for ALL in children: TCCSG L92-13E study.

Author

Kato, Motohiro, primary, Manabe, Atsushi, additional, Ishimaru, Sae, additional, Seki, Masafumi, additional, Yoshida, Kenichi, additional, Tomizawa, Daisuke, additional, Hasegawa, Daisuke, additional, Inukai, Takeshi, additional, Arakawa, Yuki, additional, Aoki, Takahiro, additional, Okuya, Mayuko, additional, Kaizu, Kiyohiko, additional, Kato, Keisuke, additional, Taneyama, Yuichi, additional, Ogawa, Seishi, additional, Koh, Katsuyoshi, additional, Tsuchida, Masahiro, additional, and Ohara, Akira, additional

Published
2015
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32. Nationwide Survey of Pediatric Hypodiploid Acute Lymphoblastic Leukemia in Japan

Author

Ishimaru, Sae, Okamoto, Yasuhiro, Imai, Chihaya, Sakaguchi, Hirotoshi, Taki, Tomohiko, Hasegawa, Daisuke, Cho, Yuko, Kakuda, Harumi, Sano, Hideki, Manabe, Atushi, Imamura, Toshihiko, Kato, Motohiro, Arakawa, Yuki, Shimonodan, Hidemi, Sato, Atsushi, Suenobu, So-ichi, Inukai, Takeshi, Watanabe, Arata, Kawano, Yoshifumi, Kikuta, Atsushi, Horibe, Keizo, Ohara, Akira, and Koh, Katsuyoshi

Published
2017
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33. Clinical Significance of Natural Killer Cell-Mediated Alloreactivity in Unrelated Cord Blood Transplantation for Children with Acute Leukemia: A Japanese National Registry Study

Author

Sakaguchi, Hirotoshi, Arima, Nobuyoshi, Narita, Atsushi, Ishimaru, Sae, Tomizawa, Daisuke, Hasegawa, Daiichiro, Kato, Motohiro, Ishida, Hiroyuki, Kanda, Junya, Inoue, Masami, Yoshida, Nao, Koh, Katsuyoshi, Inagaki, Jiro, Ogawa, Atsushi, Hori, Tsukasa, Hashii, Yoshiko, Kato, Koji, and Atsuta, Yoshiko

Published
2017
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34. Long-Term Outcome of Six Months Maintenance Chemotherapy for ALL in Children: An Extended Follow up Study of TCCSG L92-13

Author

Kato, Motohiro, primary, Manabe, Atsushi, additional, Ishimaru, Sae, additional, Tomizawa, Daisuke, additional, Hasegawa, Daisuke, additional, Inukai, Takeshi, additional, Arakawa, Yuki, additional, Aoki, Takahiro, additional, Okuya, Mayuko, additional, Kaizu, Kiyohiko, additional, Kato, Keisuke, additional, Taneyama, Yuichi, additional, Koh, Katsuyoshi, additional, Tsuchida, Masahiro, additional, and Ohara, Akira, additional

Published
2014
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37. Nationwide study of pediatric B-cell precursor acute lymphoblastic leukemia with chromosome 8q24/MYC rearrangement in Japan.

Author

Sakaguchi K, Imamura T, Ishimaru S, Imai C, Shimonodan H, Fujita N, Okada K, Taketani T, Kanai R, Tauchi H, Kato M, Kojima Y, Watanabe A, Deguchi T, Hashii Y, Kiyokawa N, Taki T, Saito AM, Horibe K, Manabe A, Sato A, and Koh K

Subjects
Adolescent, Child, Child, Preschool, Female, Follow-Up Studies, Humans, Infant, Male, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma epidemiology, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma pathology, Prognosis, Retrospective Studies, Biomarkers, Tumor genetics, Chromosomes, Human, Pair 8 genetics, Gene Rearrangement, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma genetics, Proto-Oncogene Proteins c-myc genetics
Abstract

Background: Rearrangements of chromosome 8q24/MYC (8q24/MYC-r), resulting from t(8;14)(q24;q32), t(2;8)(p11;q24), or t(8;22)(q24;q11), are mainly associated with Burkitt lymphoma/leukemia (BL) and rarely observed in patients with B-cell precursor acute lymphoblastic leukemia (BCP-ALL). The characteristics of BCP-ALL with 8q24/MYC-r are poorly understood., Procedure: A retrospective nationwide study of data from patients with pediatric BCP-ALL with 8q24/MYC-r in Japan was conducted to clarify the clinical and biological characteristics associated with 8q24/MYC-r BCP-ALL., Results: Ten patients with BCP-ALL with 8q24/MYC-r, including three with double-hit leukemia (DHL) (two with t(8;14)(q24;q32) and t(14;18)(q32;q21) and one with t(8;14) and t(3;22)(q27;q11)), were identified. Patients with BCP-ALL with 8q24/MYC-r had higher median age and uric acid and lactate dehydrogenase levels, than those without 8q24/MYC-r. All patients were initially treated with ALL-type chemotherapy; however, four, including one with DHL, were switched to BL-type chemotherapy, based on cytogenetic findings. One patient relapsed after standard-risk ALL-type chemotherapy, and two patients with DHL did not attain complete remission with chemotherapy; all three died within 11 months. The other seven patients treated with BL-type or high-risk ALL-type chemotherapy are alive without disease., Conclusions: The clinical and laboratory features of BL with IG-MYC rearrangement, displaying a BCP immunophenotype (Wagener et al. and Herbrueggen et al. termed it as pre-BLL), are similar to those of BCP-ALL with 8q24/MYC-r. Low-risk ALL-type chemotherapy may not be appropriate for them, and further studies are required to establish an adequate therapeutic strategy. Further studies of DHL to identify new treatment strategies are also needed., (© 2020 Wiley Periodicals, Inc.)

Published
2020
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38. [Successful treatment of very severe late-onset sinusoidal obstruction syndrome with recombinant human soluble thrombomodulin, steroids, and control of intra-abdominal pressure].

Author

Hirakawa T, Tanaka T, Matsumi J, Takeda W, Kim SW, Inamoto Y, Ito A, Yamaguchi K, Ishimaru S, Kumamoto T, Arakawa A, Sugiyama M, Dan L, Shigematsu M, Sato T, Ogawa C, and Fukuda T

Subjects
Adolescent, Disseminated Intravascular Coagulation, Female, Hematopoietic Stem Cell Transplantation, Humans, Multiple Organ Failure, Thrombomodulin, Hepatic Veno-Occlusive Disease
Abstract

We report a case of a 16-year-old woman who achieved her third complete remission of acute lymphoblastic leukemia after undergoing allogeneic stem cell transplantation for the second time from an unrelated donor. On post-transplantation day 30, she showed weight gain, hepatomegaly, right hypochondriac pain, and ascites. On day 35, ultrasonography (US) revealed portal vein regurgitation. She was subsequently diagnosed with late-onset sinusoidal obstruction syndrome (SOS) and was transferred to the intensive care unit (ICU) on day 36 for multiple organ dysfunction syndrome (MODS) and disseminated intravascular coagulation, requiring mechanical ventilation. Her SOS was graded as very severe upon ICU admission. Recombinant human soluble thrombomodulin (380 U/kg/day) and methylprednisolone (2 mg/kg/day) therapies were initiated. Additionally, her intra-abdominal pressure had increased to 19 mmHg, which was thought to be the cause of MODS. Ascites drainage (1,000 ml/day), according to the treatment for abdominal compartment syndrome, improved her SOS and MODS. She was weaned from mechanical ventilation on the 10th day after ICU transfer, and US showed resolution of the portal vein regurgitation. She was transferred to the general ward on the 14th day. She had not experienced disease recurrence at her last visit (527 days after the second transplantation).

Published
2020
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