Topp, Max S. and Gokbuget, Nicola and Zugmaier, Gerhard and Klappers, Petra and Stelljes, Matthias and Neumann, Svenja and Viardot, Andreas and Marks, Reinhard and Diedrich, Helmut and Faul, Christoph and Reichle, Albrecht and Horst, Heinz-August and Brueggemann, Monika and Wessiepe, Dorothea and Holland, Chris and Alekar, Shilpa and Mergen, Noemi and Einsele, Hermann and Hoelzer, Dieter and Bargou, Ralf C. (2014) Phase II Trial of the Anti-CD19 Bispecific T Cell-Engager Blinatumomab Shows Hematologic and Molecular Remissions in Patients With Relapsed or Refractory B-Precursor Acute Lymphoblastic Leukemia. JOURNAL OF CLINICAL ONCOLOGY, 32 (36). 4134-U363. ISSN 0732-183X, 1527-7755
Full text not available from this repository. (Request a copy)Abstract
Purpose Patients with relapsed or refractory acute lymphoblastic leukemia (ALL) have a dismal prognosis. CD19 is homogenously expressed in B-precursor ALL and can be targeted by the investigational bispecific T cell-engager antibody blinatumomab. A phase II trial was performed to determine clinical activity in this patient cohort. Patients and Methods Thirty-six patients with relapsed or refractory B-precursor ALL were treated with blinatumomab in cycles of 4-week continuous infusion followed by a 2-week treatment-free interval in a single-arm study with a dose-finding stage and an extension stage. The primary end point was complete remission (CR) or CR with partial hematologic recovery (CRh). Major secondary end points included minimal residual disease (MRD) response, rate of allogeneic hematopoietic stem-cell transplantation (HSCT) realization, relapse-free survival (RFS), overall survival (OS), and incidence of adverse events (AEs). Results Median age was 32 years (range, 18 to 77 years). Twenty-five patients (69%) achieved a CR or CRh, with 88% of the responders achieving an MRD response. Median OS was 9.8 months (95% CI, 8.5 to 14.9), and median RFS was 7.6 months (95% CI, 4.5 to 9.5). Thirteen responders (52%) underwent HSCT after achieving a CR or CRh. The most frequent AE during treatment was pyrexia (grade 1 or 2, 75%; grade 3, 6%). In six patients with nervous system or psychiatric disorder AEs and in two patients with cytokine release syndrome, treatment had to be interrupted or discontinued. These medical events were resolved clinically. Conclusion The data support further investigation of blinatumomab for the treatment of adult patients with relapsed or refractory ALL in a larger confirmatory study. (C) 2014 by American Society of Clinical Oncology
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ACUTE LYMPHOCYTIC-LEUKEMIA; ANTIBODY BLINATUMOMAB; INOTUZUMAB OZOGAMICIN; FREE SURVIVAL; LINEAGE; TRANSPLANTATION; CHEMOTHERAPY; PROGNOSIS; FAILURE; SALVAGE; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 05 Aug 2019 08:24 |
| Last Modified: | 05 Aug 2019 08:24 |
| URI: | https://pred.uni-regensburg.de/id/eprint/9034 |
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