Blinatumomab for Acute Lymphoblastic Leukemia Relapse after Allogeneic Hematopoietic Stem Cell Transplantation
Stein, A. S. (City of Hope Medical Center (Duarte, Estats Units d'Amèrica))
Kantarjian, H. (The University of Texas M.D. Anderson Cancer Center)
Gökbuget, Nicola (Department of Medicine II. Goethe University)
Bargou, R. C. (Comprehensive Cancer Center Mainfranken. University Hospital Würzburg)
Litzow, Mark (Mayo Clinic (Rochester, Estats Units d'Amèrica))
Rambaldi, Alessandro (Department of Oncology and Hemato-Oncology. University of Milan and Azienda Pope John XXIII Hospital)
Ribera, Jose-Maria (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Zhang, A. (Amgen Inc.)
Zimmerman, Z. (Amgen Inc.)
Zugmaier, Gerhard (Amgen Research Munich)
Topp, M. S. (Medical Clinic and Polyclinic II. University Hospital Würzburg)
Universitat Autònoma de Barcelona

Date:	2019
Abstract:	Patients with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) following allogeneic hematopoietic stem cell transplantation (alloHSCT) have a poor prognosis, and alternative therapies are needed for this patient population. Blinatumomab, a bispecific T cell engager immunotherapy, was evaluated in an open-label, single-arm, phase II study of adults with R/R Philadelphia chromosome-negative B cell precursor ALL and resulted in a rate of complete remission (CR) or CR with partial hematologic recovery of peripheral blood counts (CRh) of 43% within 2 treatment cycles. We conducted an exploratory analysis to determine the efficacy and safety of blinatumomab in 64 patients who had relapsed following alloHSCT before enrollment in the phase II study. Forty-five percent of the patients (29 of 64) achieved a CR/CRh within the first 2 cycles of treatment, 22 of whom had a minimal residual disease (MRD) response (including 19 with a complete MRD response). After 1 year and 3 years of follow-up, the median relapse-free survival was 7. 4 months for patients who achieved CR/CRh in the first 2 cycles, and the median overall survival was 8. 5 months; overall survival rate (Kaplan-Meier estimate) was 36% at 1 year and 18% at 3 years. Grade 3 and 4 adverse events were reported in 20 patients (31%) and 28 patients (44%), respectively, with grade 3 and 4 neurologic events in 8 and 2 patients, respectively, and grade 3 cytokine release syndrome in 2 patients. Eight patients had fatal adverse events, including 5 due to infections. Seven patients had grade ≤ 3 graft-versus-host disease during the study, none of which resulted in the discontinuation of blinatumomab or hospitalization. Our data suggest that blinatumomab is an effective salvage therapy in this patient population.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Paraula clau Allogeneic hematopoietic stem cell transplantation ; Paraula clau Blinatumomab ; Paraula clau Efficacy ; Paraula clau Philadelphia chromosome-negative B precursor ALL ; Paraula clau Safety
Published in:	Biology of blood and marrow transplantation, Vol. 25 Núm. 8 (august 2019) , p. 1498-1504, ISSN 1523-6536

DOI: 10.1016/j.bbmt.2019.04.010
PMID: 31002989

7 p, 820.3 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP) > Josep Carreras Leukaemia Research Institute
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