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1. Response to brentuximab vedotin versus physician’s choice by CD30 expression and large cell transformation status in patients with mycosis fungoides: An ALCANZA sub-analysis

Author

Kim, Youn H, Prince, H Miles, Whittaker, Sean, Horwitz, Steven M, Duvic, Madeleine, Bechter, Oliver, Sanches, Jose A, Stadler, Rudolf, Scarisbrick, Julia, Quaglino, Pietro, Zinzani, Pier Luigi, Wolter, Pascal, Eradat, Herbert, Pinter-Brown, Lauren C, Ortiz-Romero, Pablo L, Akilov, Oleg E, Trotman, Judith, Taylor, Kerry, Weichenthal, Michael, Walewski, Jan, Fisher, David, McNeeley, Marise, Gru, Alejandro A, Brown, Lisa, Palanca-Wessels, M Corinna, Lisano, Julie, Onsum, Matthew, Bunn, Veronica, Little, Meredith, Trepicchio, William L, and Dummer, Reinhard

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Lymphoma, Clinical Research, Hematology, Orphan Drug, Cancer, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Immunological, Brentuximab Vedotin, Choice Behavior, Decision Support Techniques, Female, Follow-Up Studies, Humans, International Agencies, Ki-1 Antigen, Male, Middle Aged, Mycosis Fungoides, Physicians, Prognosis, Retrospective Studies, Survival Rate, Young Adult, Antibody-drug conjugate, Brentuximab vedotin, CD30, Cutaneous T-cell lymphoma, Efficacy, Large-cell transformation, Mycosis fungoides, Objective response, Progression-free survival, Safety, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

IntroductionMycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma, can lead to disfiguring lesions, debilitating pruritus and frequent skin infections. This study assessed response to brentuximab vedotin in patients with MF in the phase III ALCANZA study.MethodsBaseline CD30 levels and large-cell transformation (LCT) status were centrally reviewed in patients with previously-treated CD30-positive MF using ≥2 skin biopsies obtained at screening; eligible patients required ≥1 biopsy with ≥10% CD30 expression. Patients were categorised as CD30min

Published
2021

3. Durable Survival Outcomes in Primary and Secondary Central Nervous System Lymphoma After High-dose Chemotherapy and Autologous Stem Cell Transplantation Using a Thiotepa, Busulfan, and Cyclophosphamide Conditioning Regimen

Author

Young, Patricia A, Gaut, Daria, Kimaiyo, Davis K, Grotts, Jonathan, Romero, Tahmineh, Chute, John, Schiller, Gary, de Vos, Sven, Eradat, Herbert A, and Timmerman, John

Subjects
Rare Diseases, Lymphoma, Hematology, Transplantation, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Aged, Antineoplastic Combined Chemotherapy Protocols, Busulfan, Central Nervous System Neoplasms, Cyclophosphamide, Disease-Free Survival, Female, Humans, Male, Middle Aged, Retrospective Studies, Thiotepa, ASCT, Non-Hodgkin lymphoma, PCNSL, Relapse, SCNL, Clinical Sciences, Oncology and Carcinogenesis
Abstract

BackgroundHigh-dose chemotherapy (HDC) with autologous stem cell transplantation (ASCT) has been investigated in patients with primary central nervous system lymphoma (PCNSL) and non-Hodgkin lymphoma (NHL) with CNS involvement and has shown promising results.Patients and methodsA retrospective analysis was performed of 48 consecutive patients who had undergone HDC/ASCT with TBC (thiotepa, busulfan, cyclophosphamide) conditioning for PCNSL (27 patients), secondary CNS lymphoma (SCNSL) (8 patients), or relapsed disease with CNS involvement (13 patients) from July 2006 to December 2017. Of the 27 patients with PCNSL, 21 had undergone ASCT at first complete remission (CR1).ResultsThe 2-year progression-free survival (PFS) rate was 80.5% (95% confidence interval [CI], 69.9-92.9) and the 2-year overall survival (OS) rate was 80.1% (95% CI, 69.2%-92.7%) among all patients. The 2-year PFS and OS rate for patients with PCNSL in CR1 was 95.2% (95% CI, 86.6%-100%) and 95.2% (95% CI, 86.6%-100%), respectively. On univariate analysis of the patients with PCNSL, ASCT in CR1 was the only variable statistically significant for outcome (P = .007 for PFS; P = .008 for OS). Among patients with SCNSL or CNS relapse, the 2-year PFS and OS rate were comparable at 75.9% (95% CI, 59.5%-96.8%) and 75.3% (95% CI, 58.6%-98.6%), respectively. The most common side effects were febrile neutropenia (89.6%; of which 66.7% had an infectious etiology identified), nausea/vomiting (85.4%), diarrhea (93.8%), mucositis (89.6%), and electrolyte abnormalities (89.6%). Four patients (8.3%) died of treatment-related overwhelming infection; of these patients, 3 had SCNSL.ConclusionHDC and ASCT using TBC conditioning for both PCNSL and secondary CNS NHL appears to have encouraging long-term efficacy with manageable side effects.

Published
2020

4. Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia.

Author

Sharman, Jeff, Coutre, Steven, Furman, Richard, Cheson, Bruce, Pagel, John, Hillmen, Peter, Barrientos, Jacqueline, Zelenetz, Andrew, Flinn, Ian, Ghia, Paolo, Eradat, Herbert, Ervin, Thomas, Lamanna, Nicole, Coiffier, Bertrand, Pettitt, Andrew, Ma, Shuo, Tausch, Eugen, Cramer, Paula, Huang, Julie, Mitra, Siddhartha, Hallek, Michael, Stilgenbauer, Stephan, OBrien, Susan, and Kipps, Thomas

Subjects
Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Disease Progression, Double-Blind Method, Drug Administration Schedule, Europe, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Middle Aged, Progression-Free Survival, Purines, Quinazolinones, Recurrence, Rituximab, Time Factors, United States
Abstract

PURPOSE: A randomized, double-blind, phase III study of idelalisib (IDELA) plus rituximab versus placebo plus rituximab in patients with relapsed chronic lymphocytic leukemia (CLL) was terminated early because of superior efficacy of the IDELA-plus-rituximab (IDELA/R) arm. Patients in either arm could then enroll in an extension study to receive IDELA monotherapy. Here, we report the long-term efficacy and safety data for IDELA-treated patients across the primary and extension studies. PATIENTS AND METHODS: Patients were randomly assigned to receive rituximab in combination with either IDELA 150 mg twice daily (IDELA/R; n = 110) or placebo (placebo/R; n = 110). Key end points were progression-free survival (PFS), overall response rate (ORR), overall survival (OS), and safety. RESULTS: The long-term efficacy and safety of treatment with IDELA was assessed in 110 patients who received at least one dose of IDELA in the primary study, 75 of whom enrolled in the extension study. The IDELA/R-to-IDELA group had a median PFS of 20.3 months (95% CI, 17.3 to 26.3 months) after a median follow-up time of 18 months (range, 0.3 to 67.6 months). The ORR was 85.5% (94 of 110 patients; n = 1 complete response). The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively. Prolonged exposure to IDELA increased the incidence of all-grade, grade 2, and grade 3 or greater diarrhea (46.4%, 17.3%, and 16.4%, respectively), all-grade and grade 3 or greater colitis (10.9% and 8.2%, respectively) and all-grade and grade 3 or greater pneumonitis (10.0% and 6.4%, respectively) but did not increase the incidence of elevated hepatic aminotransferases. CONCLUSION: IDELA improved PFS and OS compared with rituximab alone in patients with relapsed CLL. Long-term IDELA was effective and had an expected safety profile. No new IDELA-related adverse events were identified with longer exposure.

Published
2019

5. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data

Author

Horwitz, Steven M., Scarisbrick, Julia J., Dummer, Reinhard, Whittaker, Sean, Duvic, Madeleine, Kim, Youn H., Quaglino, Pietro, Zinzani, Pier Luigi, Bechter, Oliver, Eradat, Herbert, Pinter-Brown, Lauren, Akilov, Oleg E., Geskin, Larisa, Sanches, Jose A., Ortiz-Romero, Pablo L., Weichenthal, Michael, Fisher, David C., Walewski, Jan, Trotman, Judith, Taylor, Kerry, Dalle, Stephane, Stadler, Rudolf, Lisano, Julie, Bunn, Veronica, Little, Meredith, and Prince, H. Miles

Published
2021
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7. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 2.2024

Author

Wierda, William G., primary, Brown, Jennifer, additional, Abramson, Jeremy S., additional, Awan, Farrukh, additional, Bilgrami, Syed F., additional, Bociek, Greg, additional, Brander, Danielle, additional, Cortese, Matthew, additional, Cripe, Larry, additional, Davis, Randall S., additional, Eradat, Herbert, additional, Fakhri, Bita, additional, Fletcher, Christopher D., additional, Gaballa, Sameh, additional, Hamid, Muhammad Saad, additional, Hill, Brian, additional, Kaesberg, Paul, additional, Kahl, Brad, additional, Kamdar, Manali, additional, Kipps, Thomas J., additional, Ma, Shuo, additional, Mosse, Claudio, additional, Nakhoda, Shazia, additional, Parikh, Sameer, additional, Schorr, Andrew, additional, Schuster, Stephen, additional, Seshadri, Madhav, additional, Siddiqi, Tanya, additional, Stephens, Deborah M., additional, Thompson, Meghan, additional, Ujjani, Chaitra, additional, Valdez, Riccardo, additional, Wagner-Johnston, Nina, additional, Woyach, Jennifer A., additional, Sundar, Hema, additional, and Dwyer, Mary, additional

Published
2024
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8. A phase 2 study of the BH3 mimetic BCL2 inhibitor navitoclax (ABT-263) with or without rituximab, in previously untreated B-cell chronic lymphocytic leukemia

Author

Kipps, Thomas J, Eradat, Herbert, Grosicki, Sebastian, Catalano, John, Cosolo, Walter, Dyagil, Iryna S, Yalamanchili, Sreeni, Chai, Akiko, Sahasranaman, Srikumar, Punnoose, Elizabeth, Hurst, Deborah, and Pylypenko, Halyna

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Lymphoma, Cancer, Clinical Trials and Supportive Activities, Clinical Research, Rare Diseases, Hematology, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Aniline Compounds, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Female, Humans, Kaplan-Meier Estimate, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Middle Aged, Proto-Oncogene Proteins c-bcl-2, Rituximab, Sulfonamides, Treatment Outcome, B-cell, BH3, chronic lymphocytic leukemia, rituximab, clinical trial, ABT-263, BCL2, navitoclax, Clinical Sciences, Immunology, Cardiovascular medicine and haematology
Abstract

We evaluated the safety and biologic activity of the BH3 mimetic protein, navitoclax, combined with rituximab, in comparison to rituximab alone. One hundred and eighteen patients with chronic lymphocytic leukemia (CLL) were randomized to receive eight weekly doses of rituximab (arm A), eight weekly doses of rituximab plus daily navitoclax for 12 weeks (arm B) or eight weekly doses of rituximab plus daily navitoclax until disease progression or unacceptable toxicity (arm C). Investigator-assessed overall response rates (complete [CR] and partial [PR]) were 35% (arm A), 55% (arm B, p = 0.19 vs. A) and 70% (arm C, p = 0.0034 vs. A). Patients with del(17p) or high levels of BCL2 had significantly better clinical responses when treated with navitoclax. Navitoclax in combination with rituximab was well tolerated as initial therapy for patients with CLL, yielded higher response rates than rituximab alone and resulted in prolonged progression-free survival with treatment beyond 12 weeks.

Published
2015

9. Idelalisib and Rituximab in Relapsed Chronic Lymphocytic Leukemia

Author

Furman, Richard R, Sharman, Jeff P, Coutre, Steven E, Cheson, Bruce D, Pagel, John M, Hillmen, Peter, Barrientos, Jacqueline C, Zelenetz, Andrew D, Kipps, Thomas J, Flinn, Ian, Ghia, Paolo, Eradat, Herbert, Ervin, Thomas, Lamanna, Nicole, Coiffier, Bertrand, Pettitt, Andrew R, Ma, Shuo, Stilgenbauer, Stephan, Cramer, Paula, Aiello, Maria, Johnson, Dave M, Miller, Langdon L, Li, Daniel, Jahn, Thomas M, Dansey, Roger D, Hallek, Michael, and O'Brien, Susan M

Subjects
Cancer, Lymphoma, Clinical Research, Clinical Trials and Supportive Activities, Hematology, Patient Safety, Rare Diseases, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Aged, Aged, 80 and over, Antibodies, Monoclonal, Murine-Derived, Antineoplastic Combined Chemotherapy Protocols, Disease-Free Survival, Double-Blind Method, Female, Humans, Kaplan-Meier Estimate, Kidney Diseases, Leukemia, Lymphocytic, Chronic, B-Cell, Lymph Nodes, Male, Middle Aged, Phosphoinositide-3 Kinase Inhibitors, Purines, Quinazolinones, Recurrence, Rituximab, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundPatients with relapsed chronic lymphocytic leukemia (CLL) who have clinically significant coexisting medical conditions are less able to undergo standard chemotherapy. Effective therapies with acceptable side-effect profiles are needed for this patient population.MethodsIn this multicenter, randomized, double-blind, placebo-controlled, phase 3 study, we assessed the efficacy and safety of idelalisib, an oral inhibitor of the delta isoform of phosphatidylinositol 3-kinase, in combination with rituximab versus rituximab plus placebo. We randomly assigned 220 patients with decreased renal function, previous therapy-induced myelosuppression, or major coexisting illnesses to receive rituximab and either idelalisib (at a dose of 150 mg) or placebo twice daily. The primary end point was progression-free survival. At the first prespecified interim analysis, the study was stopped early on the recommendation of the data and safety monitoring board owing to overwhelming efficacy.ResultsThe median progression-free survival was 5.5 months in the placebo group and was not reached in the idelalisib group (hazard ratio for progression or death in the idelalisib group, 0.15; P

Published
2014

12. P1125: DURABLES RESPONSES ACHIEVED WITH ANTI-CD19 ALLOGENEIC CAR T ALLO-501/501A IN PHASE 1 TRIALS OF AUTOLOGOUS CAR T-NAÏVE PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (R/R LBCL)

Author

Munoz, Javier, primary, Locke, Frederick, additional, Lekakis, Lazaros, additional, Eradat, Herbert, additional, Tees, Michael, additional, de Vos, Sven, additional, Nath, Rajneesh, additional, Stevens, Don, additional, Malik, Shahbaz, additional, Popplewell, Leslie, additional, Hamadani, Mehdi, additional, Oluwole, Olalekan, additional, Perales, Miguel-Angel, additional, Miklos, David, additional, Fisher, Paul, additional, Goyal, Lovely, additional, Navale, Lynn, additional, Kaufman, Gregory, additional, Kai, Kazuharu, additional, Balakumaran, Arun, additional, and Neelapu, Sattva, additional

Published
2023
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13. P628: UPDATED ANALYSIS OF BELLWAVE-001: A PHASE 1/2 OPEN-LABEL DOSE-EXPANSION STUDY OF THE EFFICACY AND SAFETY OF NEMTABRUTINIB FOR THE TREATMENT OF B-CELL MALIGNANCIES

Author

Woyach, Jennifer, primary, Flinn, Ian W., additional, Awan, Farrukh, additional, Eradat, Herbert, additional, Brander, Danielle M., additional, Tees, Michael, additional, Parikh, Sameer, additional, Phillips, Tycel, additional, Ghori, Razi, additional, Paydar, Ima, additional, Farooqui, Mohammed Z. H., additional, Byrd, John C., additional, and Stephens, Deborah, additional

Published
2023
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14. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial

Author

Trotman, Judith, Joske, David, Prince, H. Miles, Taylor, Kerry, Lewis, Ian D., Jonak, Constanze, Trautinger, Franz, Bechter, Oliver, Wolter, Pascal, Bron, Dominique, de Lima, Vladmir Claudio C., Sanches, Jose Antonio, Junior, Klasa, Richard, Bagot, Martine, Beylot-Barry, Marie, Dalle, Stephane, D'Incan, Michel, Dreno, Brigitte, Grange, Florent, Nicolay, Jan, Stadler, Rudolf, Weichenthal, Michael, Wobser, Marion, Assaf, Chalid, Loquai, Carmen, Quaglino, Pietro, Spina, Michele, Zinzani, Pier Luigi, Bosi, Alberto, Fattori, Pier Paolo, Grzanka, Aleksandra, Walewski, Jan, Lopez-Hernandez, Andres, Ortiz-Romero, Pablo L., Roca, Jose Juan Rifon, Canales, Silvana Novelli, Dummer, Reinhard, Illidge, Timothy, Johnson, Rod, Whittaker, Sean, Morris, Stephen, McKay, Pam, Scarisbrick, Julia, Duvic, Madeleine, Feldman, Tatyana, Akilov, Oleg, Geskin, Larisa, Horwitz, Steve, Kim, Youn H., Pro, Barbara, Kuzel, Timothy, Lerner, Adam, Eradat, Herbert, Sokol, Lubomir, Fisher, David C., Hughey, Sarah, Prince, H Miles, Kim, Youn H, Horwitz, Steven M, Sanches, Jose A, Ortiz-Romero, Pablo L, Akilov, Oleg E, Fisher, David, Dréno, Brigitte, Kuzel, Timothy M, Wang, Yinghui, Palanca-Wessels, Maria Corinna, Zagadailov, Erin, Trepicchio, William L, Zhang, Wenwen, Lin, Hui-Min, Liu, Yi, Huebner, Dirk, and Little, Meredith

Published
2017
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16. Diversification of T Cell Responses to Carboxy-terminal Determinants within the 65-kD Heat-shock Protein Is Involved in Regulation of Autoimmune Arthritis

Author

Moudgil, Kamal D, Chang, Tammy T, Eradat, Herbert, Chen, Audrey M, Gupta, Radhey S, Brahn, Ernest, and Sercarz, Eli E

Subjects
Aging, Autoimmune Disease, Arthritis, Rare Diseases, Prevention, Infectious Diseases, Aetiology, 2.1 Biological and endogenous factors, Inflammatory and immune system, Good Health and Well Being, Amino Acid Sequence, Animals, Antigens, Bacterial, Arthritis, Experimental, Arthritis, Rheumatoid, Bacterial Proteins, Chaperonin 60, Chaperonins, Epitopes, Male, Models, Immunological, Molecular Sequence Data, Mycobacterium tuberculosis, Peptide Fragments, Rats, Rats, Inbred Lew, Rats, Inbred WKY, T-Lymphocytes, Time Factors, Vaccination, Medical and Health Sciences, Immunology
Abstract

The T cell response to the 65-kD mycobacterial heat-shock protein (Bhsp65) has been implicated in the pathogenesis of autoimmune arthritis. Adjuvant arthritis (AA) induced in the Lewis rat (RT-1(l)) by injection of Mycobacterium tuberculosis serves as an experimental model for human rheumatoid arthritis (RA). However, the immunological basis of regulation of acute AA, or of susceptibility/resistance to AA is not known. We have defined the specificity of the proliferative T cell responses to Bhsp65 during the course of AA in the Lewis rat. During the early phase of the disease (6-9 d after onset of AA), Lewis rats raised T cell responses to many determinants within Bhsp65, spread throughout the molecule. Importantly, in the late phase of the disease (8-10 wk after onset of AA), there was evidence for diversification of the T cell responses toward Bhsp65 carboxy-terminal determinants (BCTD) (namely, 417-431, 441-455, 465-479, 513-527, and 521-535). Moreover, arthritic rats in the late phase of AA also raised vigorous T cell responses to those carboxy-terminal determinants within self(rat) hsp65 (Rhsp65) that correspond in position to the above BCTD. These results suggest that the observed diversification is possibly triggered in vivo by induction of self(Rhsp65)-reactive T cells. Interestingly, another strain of rat, the Wistar Kyoto (WKY/NHsd) rat (RT-1(l)), with the same major histocompatibility complex class II molecules as the Lewis rat, was found to be resistant to AA. In WKY rats, vigorous responses to the BCTD, to which the Lewis rat responded only in the late phase of AA, were observed very early, 10 d after injection of M. tuberculosis, Strikingly, pretreatment with the peptides comprising the set of BCTD, but not its amino-terminal determinants, provided significant protection to naive Lewis rats from subsequent induction of AA. Thus, T cell responses to the BCTD are involved in regulating inflammatory arthritis in the Lewis rat and in conferring resistance to AA in the WKY rat. These results have important implications in understanding the pathogenesis of RA and in devising new immunotherapeutic strategies for this disease.

Published
1997

19. Subcutaneous Epcoritamab in Patients with Richter's Syndrome: Early Results from Phase 1b/2 Trial (EPCORE CLL-1)

Author

Kater, Arnon P., primary, Ye, J Christine, additional, Sandoval-Sus, Jose, additional, Bellido, Mar, additional, Christensen, Jacob Haaber, additional, Mato, Anthony R., additional, Janssens, Ann, additional, Oki, Toshihiko, additional, Hoehn, Daniela, additional, Rios, Marcia, additional, Kuznetsova, Alexandra, additional, Valentin, Rebecca, additional, and Eradat, Herbert, additional

Published
2022
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21. Efficacy and Safety of Nemtabrutinib, a Wild-Type and C481S-Mutated Bruton Tyrosine Kinase Inhibitor for B-Cell Malignancies: Updated Analysis of the Open-Label Phase 1/2 Dose-Expansion Bellwave-001 Study

Author

Woyach, Jennifer A., primary, Flinn, Ian W., additional, Awan, Farrukh T., additional, Eradat, Herbert, additional, Brander, Danielle, additional, Tees, Michael, additional, Parikh, Sameer A., additional, Phillips, Tycel J., additional, Ghori, Razi, additional, Reddy, Nishitha M., additional, Farooqui, Mohammed Z.H., additional, Byrd, John C., additional, and Stephens, Deborah M., additional

Published
2022
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22. Mosunetuzumab Monotherapy Continues to Demonstrate Promising Efficacy and Durable Complete Responses in Elderly/Unfit Patients with Previously Untreated Diffuse Large B-Cell Lymphoma

Author

Olszewski, Adam J., primary, Avigdor, Abraham, additional, Babu, Sunil, additional, Levi, Itai, additional, Eradat, Herbert, additional, Abadi, Uri, additional, Holmes, Houston, additional, McKinney, Matthew, additional, Woszczyk, Dariusz, additional, Giannopoulos, Krzysztof, additional, Jurczak, Wojciech, additional, Dunshee, Diana, additional, Yang, Annie, additional, Zhou, Mingzhu, additional, Qayum, Naseer, additional, Sellam, Gila, additional, and Horowitz, Netanel A., additional

Published
2022
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23. CT-419 ALPHA2: A Phase 1b Study Evaluating the CD19 Allogeneic CAR T Cell Product Cemacabtagene Ansegedleucel (Cema-Cel) in Patients With Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Author

Miklos, David, Bharadwaj, Sushma, Holmes, Houston, Oluwole, Olalekan, Jallouk, Andrew, Neelapu, Sattva, Jain, Nitin, Nath, Rajneesh, Munoz, Javier, Bryan, Locke, De Vos, Sven, Eradat, Herbert, Patel, Rushang, Tees, Michael, Tsai, Stephanie, Cahill, Kirk, Sohl, Melhem, Shouse, Geoffrey, Stevens, Don, Fisher, Paul, Feng, Amy, Severyn, Christopher, Le Gall, John, and Locke, Frederick

Published
2024
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25. ALPHA2: A Phase 1b Study Evaluating the CD19 Allogeneic CAR T Cell Product Cemacabtagene Ansegedleucel (Cema-Cel) in Patients With Relapsed/ Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Author

Miklos, David, Bharadwaj, Sushma, Holmes, Houston, Oluwole, Olalekan, Jallouk, Andrew, Neelapu, Sattva, Jain, Nitin, Nath, Rajneesh, Munoz, Javier, Bryan, Locke, De Vos, Sven, Eradat, Herbert, Patel, Rushang, Tees, Michael, Tsai, Stephanie, Cahill, Kirk, Sohl, Melhem, Shouse, Geoffrey, Stevens, Don, Fisher, Paul, Feng, Amy, Severyn, Christopher, Le Gall, John, Locke, Frederick, and Pinilla, Javier

Published
2024
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27. NCCN Guidelines® Insights: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 3.2022

Author

Wierda, William G., primary, Brown, Jennifer, additional, Abramson, Jeremy S., additional, Awan, Farrukh, additional, Bilgrami, Syed F., additional, Bociek, Greg, additional, Brander, Danielle, additional, Chanan-Khan, Asher A., additional, Coutre, Steve E., additional, Davis, Randall S., additional, Eradat, Herbert, additional, Fletcher, Christopher D., additional, Gaballa, Sameh, additional, Ghobadi, Armin, additional, Hamid, Muhammad Saad, additional, Hernandez-Ilizaliturri, Francisco, additional, Hill, Brian, additional, Kaesberg, Paul, additional, Kamdar, Manali, additional, Kaplan, Lawrence D., additional, Khan, Nadia, additional, Kipps, Thomas J., additional, Ma, Shuo, additional, Mato, Anthony, additional, Mosse, Claudio, additional, Schuster, Stephen, additional, Siddiqi, Tanya, additional, Stephens, Deborah M., additional, Ujjani, Chaitra, additional, Wagner-Johnston, Nina, additional, Woyach, Jennifer A., additional, Ye, J. Christine, additional, Dwyer, Mary A., additional, and Sundar, Hema, additional

Published
2022
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29. Anti-CD20–atezolizumab–polatuzumab vedotin in relapsed/refractory follicular and diffuse large B-cell lymphoma

Author

Topp, Max S., primary, Eradat, Herbert, additional, Florschütz, Axel, additional, Hochhaus, Andreas, additional, Wrobel, Tomasz, additional, Walewski, Jan, additional, Knopinska-Posluszny, Wanda, additional, Kanate, Abraham S., additional, Lech-Maranda, Ewa, additional, Brunnberg, Uta, additional, Chitra, Surya, additional, Nielsen, Tina G., additional, Sellam, Gila, additional, Shivhare, Mahesh, additional, and Lossos, Izidore S., additional

Published
2022
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30. Supplement to: Idelalisib and rituximab in relapsed chronic lymphocytic leukemia.

Author

Furman, Richard R., Sharman, Jeff P., Coutre, Steven E., Cheson, Bruce D., Pagel, John M., Hillmen, Peter, Barrientos, Jacqueline C., Zelenetz, Andrew D., Kipps, Thomas J., Flinn, Ian, Ghia, Paolo, Eradat, Herbert, Ervin, Thomas, Lamanna, Nicole, Coiffier, Bertrand, Pettitt, Andrew R., Ma, Shuo, Stilgenbauer, Stephan, Cramer, Paula, Aiello, Maria, Johnson, Dave M., Miller, Langdon L., Li, Daniel, Jahn, Thomas M., Dansey, Roger D., Hallek, Michael, and OʼBrien, Susan M.

Published
2014

31. Preliminary Efficacy and Safety of MK-1026, a Non-Covalent Inhibitor of Wild-Type and C481S Mutated Bruton Tyrosine Kinase, in B-Cell Malignancies: A Phase 2 Dose Expansion Study

Author

Woyach, Jennifer A., primary, Flinn, Ian W., additional, Awan, Farrukh T., additional, Eradat, Herbert, additional, Brander, Danielle M., additional, Tees, Michael, additional, Parikh, Sameer A., additional, Phillips, Tycel, additional, Wang, Wayne, additional, Reddy, Nishitha M., additional, Farooqui, Mohammed Z.H., additional, Byrd, John C., additional, and Stephens, Deborah M., additional

Published
2021
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32. ABCL-366: Mosunetuzumab (Mosun) Monotherapy for Elderly/Unfit Patients with First-Line Diffuse Large B-Cell Lymphoma (DLBCL) Continues to Show Promising Safety and Efficacy with Durable Complete Responses

Author

Olszewski, Adam, primary, Avigdor, Abraham, additional, Babu, Sunil, additional, Levi, Itai, additional, Eradat, Herbert, additional, Abadi, Uri, additional, Holmes, Houston, additional, McKinney, Matthew, additional, Woszczyk, Dariusz, additional, Giannopoulos, Krzysztof, additional, Jurczak, Wojciech, additional, McCord, Ron, additional, Xie, Yuying, additional, Zhou, Mingzhu, additional, Qayum, Naseer, additional, O’Hear, Carol, additional, Sellam, Gila, additional, and Horowitz, Netanel, additional

Published
2021
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33. Poster: ABCL-366: Mosunetuzumab (Mosun) Monotherapy for Elderly/Unfit Patients with First-Line Diffuse Large B-Cell Lymphoma (DLBCL) Continues to Show Promising Safety and Efficacy with Durable Complete Responses

Author

Olszewski, Adam, primary, Avigdor, Abraham, additional, Babu, Sunil, additional, Levi, Itai, additional, Eradat, Herbert, additional, Abadi, Uri, additional, Holmes, Houston, additional, McKinney, Matthew, additional, Woszczyk, Dariusz, additional, Giannopoulos, Krzysztof, additional, Jurczak, Wojciech, additional, McCord, Ron, additional, Xie, Yuying, additional, Zhou, Mingzhu, additional, Qayum, Naseer, additional, O’Hear, Carol, additional, Sellam, Gila, additional, and Horowitz, Netanel, additional

Published
2021
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35. Mosunetuzumab and Polatuzumab Vedotin Demonstrates Preliminary Efficacy in Elderly Unfit/Frail Patients with Previously Untreated Diffuse Large B-Cell Lymphoma

Author

Olszewski, Adam J, Eradat, Herbert, Avigdor, Abraham, Horowitz, Netanel A., Babu, Sunil, Levi, Itai, McKinney, Matthew, Lee, Seung Tae, Bergua Burgues, Juan Miguel, Rodriguez Izquierdo, Antonia, Bastos-Oreiro, Mariana, Ganzel, Chezi, Kim, Tae Min, Jeon, Youngwoo, Taszner, Michal, Narkhede, Mayur, Kim, Won Seog, Shin, Ho-Jin, Lavie, David, Woszczyk, Dariusz, Dunshee, Diana, Kapp, Amy V., Zhou, Mingzhu, Batlevi, Connie Lee, Ead, Wahib, Sellam, Gila, and Jurczak, Wojciech

Published
2023
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36. IL-1 receptor antagonist for prevention of severe immune effector cell-associated neurotoxicity syndrome.

Author

Oliai, Caspian, primary, Crosetti, Anna, additional, De Vos, Sven, additional, Eradat, Herbert, additional, Mead, Monica Diane, additional, Larson, Sarah Marie, additional, Tsai, Steven, additional, Liu, Annabel, additional, Khachatrian, Gina, additional, Hannigan, Christopher, additional, Yamada, Reiko E., additional, Rokni, Neiki, additional, and Timmerman, John, additional

Published
2021
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37. Response to brentuximab vedotin versus physician’s choice by CD30 expression and large cell transformation status in patients with mycosis fungoides: An ALCANZA sub-analysis

Author

Kim, Youn H., primary, Prince, H. Miles, additional, Whittaker, Sean, additional, Horwitz, Steven M., additional, Duvic, Madeleine, additional, Bechter, Oliver, additional, Sanches, Jose A., additional, Stadler, Rudolf, additional, Scarisbrick, Julia, additional, Quaglino, Pietro, additional, Zinzani, Pier Luigi, additional, Wolter, Pascal, additional, Eradat, Herbert, additional, Pinter-Brown, Lauren C., additional, Ortiz-Romero, Pablo L., additional, Akilov, Oleg E., additional, Trotman, Judith, additional, Taylor, Kerry, additional, Weichenthal, Michael, additional, Walewski, Jan, additional, Fisher, David, additional, McNeeley, Marise, additional, Gru, Alejandro A., additional, Brown, Lisa, additional, Palanca-Wessels, M. Corinna, additional, Lisano, Julie, additional, Onsum, Matthew, additional, Bunn, Veronica, additional, Little, Meredith, additional, Trepicchio, William L., additional, and Dummer, Reinhard, additional

Published
2021
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38. Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study

Author

Dummer, Reinhard, Prince, Henry M, Whittaker, Sean, Horwitz, Steven M, Kim, Youn H, Scarisbrick, Julia, Quaglino, Pietro, Zinzani, Pier Luigi, Wolter, Pascal, Eradat, Herbert, Pinter-Brown, Lauren, Sanches, Jose A, Ortiz-Romero, Pablo L, Akilov, Oleg E, Geskin, Larisa; https://orcid.org/0000-0001-7348-2571, Huen, Auris, Walewski, Jan, Wang, Yinghui, Lisano, Julie; https://orcid.org/0000-0003-2454-2800, Richhariya, Akshara, Feliciano, Joseph, Zhu, Yanyan, Bunn, Veronica, Little, Meredith, Zagadailov, Erin; https://orcid.org/0000-0002-4903-2762, Dalal, Mehul R, Duvic, Madeleine, Dummer, Reinhard, Prince, Henry M, Whittaker, Sean, Horwitz, Steven M, Kim, Youn H, Scarisbrick, Julia, Quaglino, Pietro, Zinzani, Pier Luigi, Wolter, Pascal, Eradat, Herbert, Pinter-Brown, Lauren, Sanches, Jose A, Ortiz-Romero, Pablo L, Akilov, Oleg E, Geskin, Larisa; https://orcid.org/0000-0001-7348-2571, Huen, Auris, Walewski, Jan, Wang, Yinghui, Lisano, Julie; https://orcid.org/0000-0003-2454-2800, Richhariya, Akshara, Feliciano, Joseph, Zhu, Yanyan, Bunn, Veronica, Little, Meredith, Zagadailov, Erin; https://orcid.org/0000-0002-4903-2762, Dalal, Mehul R, and Duvic, Madeleine

Abstract

Background: Brentuximab vedotin was approved for adult patients with CD30-expressing cutaneous T-cell lymphoma treated with prior systemic therapy based on improved response rates and progression-free survival with brentuximab vedotin (1.8 mg/kg once every 3 weeks; ≤16 cycles) versus physician's choice (methotrexate/bexarotene; ≤48 weeks) in the phase III ALCANZA study. Quality of life (QoL) in ALCANZA patients was also examined. Methods: QoL measures in ALCANZA were based on the Skindex-29, Functional Assessment of Cancer Therapy-General (FACT-G) and European QoL 5-dimension (EQ-5D) questionnaires. Results: Mean maximum reduction from the baseline Skindex-29 symptom domain score (key secondary end-point) was greater with brentuximab vedotin than physician's choice (-27.96 versus -8.62); the difference, -18.9 (95% confidence interval -26.6, -11.2; adjusted p < 0.001), exceeded the study-defined minimally important difference (9.0-12.3). Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29). EQ-5D changes were also comparable between arms. Among brentuximab vedotin-treated patients with peripheral neuropathy (PN), mean maximum reduction in Skindex-29 symptom domain was -35.54 versus -11.11 in patients without PN. PN had no meaningful effect on FACT-G and EQ-5D QoL scores. Conclusions: In summary, brentuximab vedotin produced superior reductions in symptom burden compared with physician's choice, without adversely impacting QoL. QoL was unaffected by the presence of PN in brentuximab vedotin-treated patients. Clinical trial registration: NCT01578499.

Published
2020

40. Single-Agent Mosunetuzumab Is a Promising Safe and Efficacious Chemotherapy-Free Regimen for Elderly/Unfit Patients with Previously Untreated Diffuse Large B-Cell Lymphoma

Author

Olszewski, Adam J, primary, Avigdor, Abraham, additional, Babu, Sunil, additional, Levi, Itai, additional, Abadi, Uri, additional, Holmes, Houston, additional, McKinney, Matthew, additional, McCord, Ron, additional, Xie, Yuying, additional, Chen, Cindy, additional, Sarouei, Kati, additional, Qayum, Naseer, additional, O'Hear, Carol, additional, Sellam, Gila, additional, and Eradat, Herbert, additional

Published
2020
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41. TCL-139: Safety of Mogamulizumab in Mycosis Fungoides and Sézary Syndrome: Final Results from the Phase 3 MAVORIC Study

Author

Sokol, Lubomir, primary, Duvic, Madeleine, additional, Musiek, Amy, additional, Kim, Ellen, additional, Eradat, Herbert, additional, Elmets, Craig, additional, Shinohara, Michi, additional, Fisher, David, additional, Poligone, Brian, additional, Pro, Barbara, additional, Reddy, Nishita, additional, Halwani, Ahmad, additional, Herr, Fiona, additional, Ito, Takahiro, additional, and Kim, Youn, additional

Published
2020
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42. Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study

Author

Dummer, Reinhard, primary, Prince, Henry M., additional, Whittaker, Sean, additional, Horwitz, Steven M., additional, Kim, Youn H., additional, Scarisbrick, Julia, additional, Quaglino, Pietro, additional, Zinzani, Pier Luigi, additional, Wolter, Pascal, additional, Eradat, Herbert, additional, Pinter-Brown, Lauren, additional, Sanches, Jose A., additional, Ortiz-Romero, Pablo L., additional, Akilov, Oleg E., additional, Geskin, Larisa, additional, Huen, Auris, additional, Walewski, Jan, additional, Wang, Yinghui, additional, Lisano, Julie, additional, Richhariya, Akshara, additional, Feliciano, Joseph, additional, Zhu, Yanyan, additional, Bunn, Veronica, additional, Little, Meredith, additional, Zagadailov, Erin, additional, Dalal, Mehul R., additional, and Duvic, Madeleine, additional

Published
2020
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43. MOESM1 of Idelalisib addition has neutral to beneficial effects on quality of life in bendamustine/rituximab-treated patients: results of a phase 3, randomized, controlled trial

Author

Montillo, Marco, Illés, Árpád, Robak, Tadeusz, Pristupa, Alexander, Malgorzata Wach, Egyed, Miklós, Delgado, Julio, Jurczak, Wojciech, Morschhauser, Franck, Schuh, Anna, Eradat, Herbert, Sanatan Shreay, Barrientos, Jacqueline, and Zelenetz, Andrew

Abstract

Additional file 1: Table S1. Questionnaires used to assess health-related quality of life. Table S2. Compliance rates: FACT-Leu questionnaire. Table S3. Compliance rates: EQ-5D questionnaire. Table S4. Mixed-effects model analysis estimates (idelalisib/placebo) for functional assessment of cancer therapy using FACT-Leu.

Published
2019
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44. Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia

Author

Sharman, Jeff P., Coutre, Steven E., Furman, Richard R., Cheson, Bruce D., Pagel, John M., Hillmen, Peter, Barrientos, Jacqueline C., Zelenetz, Andrew D., Kipps, Thomas J., Flinn, Ian W., Ghia, Paolo, Eradat, Herbert, Ervin, Thomas, Lamanna, Nicole, Coiffier, Bertrand, Pettitt, Andrew R., Ma, Shuo, Tausch, Eugen, Cramer, Paula, Huang, Julie, Mitra, Siddhartha, Hallek, Michael, O'Brien, Susan M., Stilgenbauer, Stephan, Sharman, Jeff P., Coutre, Steven E., Furman, Richard R., Cheson, Bruce D., Pagel, John M., Hillmen, Peter, Barrientos, Jacqueline C., Zelenetz, Andrew D., Kipps, Thomas J., Flinn, Ian W., Ghia, Paolo, Eradat, Herbert, Ervin, Thomas, Lamanna, Nicole, Coiffier, Bertrand, Pettitt, Andrew R., Ma, Shuo, Tausch, Eugen, Cramer, Paula, Huang, Julie, Mitra, Siddhartha, Hallek, Michael, O'Brien, Susan M., and Stilgenbauer, Stephan

Abstract

PURPOSE A randomized, double-blind, phase III study of idelalisib (IDELA) plus rituximab versus placebo plus rituximab in patients with relapsed chronic lymphocytic leukemia (CLL) was terminated early because of superior efficacy of the IDELA-plus-rituximab (IDELA/R) arm. Patients in either arm could then enroll in an extension study to receive IDELA monotherapy. Here, we report the long-term efficacy and safety data for IDELA-treated patients across the primary and extension studies. PATIENTS AND METHODS Patients were randomly assigned to receive rituximab in combination with either IDELA 150 mg twice daily (IDELA/R; n = 110) or placebo (placebo/R; n = 110). Key end points were progression-free survival (PFS), overall response rate (ORR), overall survival (OS), and safety. RESULTS The long-term efficacy and safety of treatment with IDELA was assessed in 110 patients who received at least one dose of IDELA in the primary study, 75 of whom enrolled in the extension study. The IDELA/R-to-IDELA group had a median PFS of 20.3 months (95% CI, 17.3 to 26.3 months) after a median follow-up time of 18 months (range, 0.3 to 67.6 months). The ORR was 85.5% (94 of 110 patients; n = 1 complete response). The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively. Prolonged exposure to IDELA increased the incidence of all-grade, grade 2, and grade 3 or greater diarrhea (46.4%, 17.3%, and 16.4%, respectively), all-grade and grade 3 or greater colitis (10.9% and 8.2%, respectively) and all-grade and grade 3 or greater pneumonitis (10.0% and 6.4%, respectively) but did not increase the incidence of elevated hepatic aminotransferases. CONCLUSION IDELA improved PFS and OS compared with rituximab alone in patients with relapsed CLL. Long-term IDELA was effective and had an expected safety profile. No new IDELA-related adverse events were identified wit

Published
2019

45. Safety of Mogamulizumab in Mycosis Fungoides and Sézary Syndrome: Final Results from the Phase 3 Mavoric Study

Author

Kim, Youn H., primary, Bagot, Martine, additional, Zinzani, Pier Luigi, additional, Duvic, Madeleine, additional, Morris, Stephen, additional, Kim, Ellen, additional, Musiek, Amy, additional, Ortiz-Romero, Pablo L., additional, Elmets, Craig, additional, Eradat, Herbert A., additional, Magnolo, Nina, additional, Scarisbrick, Julia, additional, Dalle, Stéphane, additional, Fisher, David C., additional, Shinohara, Michi, additional, Poligone, Brian, additional, Pro, Barbara, additional, Quaglino, Pietro, additional, Reddy, Nishitha, additional, Dreno, Brigitte, additional, Geskin, Larisa J, additional, Halwani, Ahmad S, additional, Khot, Amit, additional, Beylot-Barry, Marie, additional, Korman, Neil, additional, Lansigan, Frederick, additional, Horwitz, Steven M., additional, Lamar, Zanetta S., additional, Moskowitz, Alison J., additional, Wells, Jillian, additional, Akilov, Oleg E., additional, Caballero, Dolores, additional, Cowan, Richard, additional, Dummer, Reinhard, additional, Lechowicz, Mary Jo, additional, Foss, Francine M., additional, Iversen, Lars, additional, Miyagaki, Tomomitsu, additional, Wilcox, Ryan, additional, Porcu, Pierluigi, additional, Vermeer, Maarten, additional, Abhyankar, Sunil, additional, Kato, Yukihiko, additional, Pacheco, Theresa, additional, Sano, Shigetoshi, additional, William, Basem M., additional, Fenske, Timothy S., additional, Fukuhara, Noriko, additional, Habe, Koji, additional, Hamada, Toshihisa, additional, Kiyohara, Eiji, additional, Kuss, Bryone J., additional, Lerner, Adam, additional, Mark, Lawrence, additional, Munoz, Javier, additional, Okamoto, Hiroyuki, additional, Querfeld, Christiane, additional, Uehara, Jiro, additional, Uhara, Hisashi, additional, Yonekura, Kentaro, additional, Huen, Auris, additional, Tobinai, Kensei, additional, Tokura, Yoshiki, additional, Boh, Erin, additional, Nicolay, Jan, additional, Wada, Hidefumi, additional, Leoni, Mollie, additional, Ito, Takahiro, additional, Herr, Fiona, additional, and Sokol, Lubomir, additional

Published
2019
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46. Utility of positron emission tomography-computed tomography in patients with chronic lymphocytic leukemia following B-cell receptor pathway inhibitor therapy

Author

Mato, Anthony R., primary, Wierda, William G., additional, Davids, Matthew S., additional, Cheson, Bruce D., additional, Coutre, Steven E., additional, Choi, Michael, additional, Furman, Richard R., additional, Heffner, Leonard, additional, Barr, Paul M., additional, Eradat, Herbert, additional, Ford, Sharanya M., additional, Zhou, Lang, additional, Verdugo, Maria, additional, Humerickhouse, Rod A., additional, Potluri, Jalaja, additional, and Byrd, John C., additional

Published
2019
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47. Brentuximab vedotin (BV) versus physician’s choice (PC) of methotrexate or bexarotene in adult patients with previously treated CD30-positive cutaneous T-cell lymphoma (CTCL; mycosis fungoides [MF] or primary cutaneous anaplastic large cell lymphoma [pcALCL]): final time to next therapy (TTNT) results from the phase 3 ALCANZA study

Author

Scarisbrick, Julia, primary, Horwitz, Steven M., additional, Prince, H. Miles, additional, Whittaker, Sean, additional, Duvic, Madeleine, additional, Kim, Youn H., additional, Quaglino, Pietro, additional, Zinzani, Pier Luigi, additional, Bechter, Oliver, additional, Eradat, Herbert, additional, Pinter-Brown, Lauren, additional, Akilov, Oleg, additional, Geskin, Larisa, additional, Sanches, Jose, additional, Ortiz-Romero, Pablo, additional, Lisano, Julie, additional, Brown, Lisa, additional, Bunn, Veronica, additional, Little, Meredith, additional, and Dummer, Reinhard, additional

Published
2019
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48. A phase 2 study of ofatumumab in Waldenström’s macroglobulinaemia

Author

Furman¹, Richard R, Eradat, Herbert A, DiRienzo, Christine G, Hofmeister, Craig C, Hayman, Suzanne R, Leonard, John P, Coleman, Morton, Advani, Ranjana, Chanan-Khan, Asher, Switzky, Julie, Liao, Qiming M, Shah, Damini, Jewell, Roxanne C, Lisby, Steen, and Lin, Thomas S

Subjects
Adult, Aged, 80 and over, Male, Antibodies, Monoclonal, Middle Aged, Antibodies, Monoclonal, Humanized, Antigens, CD20, Article, Antineoplastic Agents, Immunological, Treatment Outcome, Immunoglobulin M, Humans, Female, Neoplasm Recurrence, Local, Waldenstrom Macroglobulinemia, Aged
Abstract

The development of more effective and safer treatments, especially non-chemotherapeutics, is needed for patients with Waldenström's macroglobulinaemia. The aim of the study was to assess the safety and clinical activity of intravenous ofatumumab monotherapy for untreated and relapsed Waldenström's macroglobulinaemia.We did a phase 2, open-label, single-arm study at six centres (hospitals and cancer clinics) in the USA. Patients aged at least 18 years who were diagnosed with untreated or relapsed Waldenström's macroglobulinaemia and required treatment, received up to three cycles of weekly ofatumumab for 5 weeks. For cycle 1, patients received one of two treatment regimens. Group A received ofatumumab 300 mg during week 1 followed by 1000 mg during weeks 2-4. Because of the acceptable safety of the 1000 mg dose in treatment group A and clinical activity of the 2000 mg dose established in chronic lymphocytic leukaemia, the study was amended on Dec 9, 2009, to change cycle 1 for group B who received ofatumumab 300 mg during week 1 and 2000 mg during weeks 2-5. We followed up patients during weeks 5-16 for treatment group A and during weeks 6-16 for treatment group B (no treatment was given during this follow-up). Patients in both groups with stable disease or a minor response after 16 weeks were eligible to then receive a redosing cycle of ofatumumab 300 mg during week 1 and 2000 mg during weeks 2-5. We followed up patients during weeks 6-16 after the redosing cycle (no treatment was given during this follow-up). Patients responding to cycle 1 or the redosing cycle who developed disease progression within 36 months could receive cycle 2 of ofatumumab 300 mg during week 1 and 2000 mg during weeks 2-5. The primary endpoint for this study was the proportion of patients who achieved an overall response (complete responses plus partial responses plus minor responses) after each treatment cycle in the intent-to-treat population every 4 weeks starting at week 8. This trial is registered at www.ClinicalTrials.gov, NCT00811733, and is now complete.Between March 17, 2009, and Feb 24, 2011, we enrolled and assigned 37 patients to treatment (15 in treatment group A and 22 in treatment group B). All 37 were included in the efficacy and safety analyses. 19 (51%, 95% CI 34·4-68·1) of 37 patients achieved an overall response after cycle 1 and 22 (59%, 42·1-75·2) of 37 achieved an overall response after the redosing cycle; 15 (41%) with partial responses, seven (19%) with minor responses. 13 patients received treatment cycle 2; ten (77%) of the 13 achieved a response. All 37 patients had at least one adverse event; 16 (43%) patients had events of grade 3 or more (30 grade 3, one grade 4). The most common grade 3 or 4 adverse events were infusion reactions (four [11%] of 37), chest pain (two [5%] of 37), haemolysis (two [5%] of 37), and neutropenia (two [5%] of 37). Two (9%) of 22 patients (both in treatment group B) had an IgM flare. 12 patients reported serious adverse events; haemolysis and pyrexia were the most common (each occurring in two [5%] of 37 patients).A high proportion of patients achieved an overall response with ofatumumab monotherapy and this treatment was well tolerated, with a low incidence of IgM flare. This therapy might be a non-chemotherapeutic treatment option for patients with Waldenström's macroglobulinaemia, especially those with high IgM concentrations.GlaxoSmithKline and Genmab.

Published
2016

49. Phase 1 Trial of Cobomarsen, an Inhibitor of Mir-155, in Cutaneous T Cell Lymphoma

Author

Querfeld, Christiane, primary, Foss, Francine M., additional, Kim, Youn H., additional, Pinter-Brown, Lauren, additional, William, Basem M., additional, Porcu, Pierluigi, additional, Pacheco, Theresa, additional, Haverkos, Bradley M., additional, DeSimone, Jennifer, additional, Guitart, Joan, additional, Halwani, Ahmad S, additional, Eradat, Herbert A., additional, Huen, Auris, additional, Schroeder, Kristin, additional, Pestano, Linda A., additional, Williams, Paul J., additional, Cheronis, Ioanna, additional, Gordon, Gilad S., additional, Escolar, Diana, additional, Rubin, Paul, additional, and Marshall, William S., additional

Published
2018
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50. Superior Clinical Benefit of Brentuximab Vedotin in Mycosis Fungoides Versus Physician's Choice Irrespective of CD30 Level or Large Cell Transformation Status in the Phase 3 ALCANZA Study

Author

Kim, Youn H., primary, Prince, H. Miles, additional, Whittaker, Sean, additional, Horwitz, Steven M., additional, Duvic, Madeleine, additional, Bechter, Oliver, additional, Sanches, Jose A., additional, Stadler, Rudolf, additional, Scarisbrick, Julia, additional, Quaglino, Pietro, additional, Zinzani, Pier Luigi, additional, Wolter, Pascal, additional, Eradat, Herbert, additional, Pinter-Brown, Lauren C., additional, Ortiz-Romero, Pablo L., additional, Akilov, Oleg E., additional, Trotman, Judith, additional, Taylor, Kerry, additional, Weichenthal, Michael, additional, Walewski, Jan, additional, Fisher, David C., additional, McNeeley, Marise, additional, Gru, Alejandro A., additional, Wang, Yinghui, additional, Palanca-Wessels, Maria Corinna, additional, Lisano, Julie, additional, Li, Martha, additional, Lin, Hui-Min, additional, Little, Meredith, additional, Trepicchio, William L., additional, and Dummer, Reinhard, additional

Published
2018
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