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Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia

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TLDR
Treatment with blinatumomab resulted in significantly longer overall survival than chemotherapy among adult patients with relapsed or refractory B‐cell precursor ALL, and remission rates within 12 weeks after treatment initiation were significantly higher.
Abstract
BackgroundBlinatumomab, a bispecific monoclonal antibody construct that enables CD3-positive T cells to recognize and eliminate CD19-positive acute lymphoblastic leukemia (ALL) blasts, was approved for use in patients with relapsed or refractory B-cell precursor ALL on the basis of single-group trials that showed efficacy and manageable toxic effects. MethodsIn this multi-institutional phase 3 trial, we randomly assigned adults with heavily pretreated B-cell precursor ALL, in a 2:1 ratio, to receive either blinatumomab or standard-of-care chemotherapy. The primary end point was overall survival. ResultsOf the 405 patients who were randomly assigned to receive blinatumomab (271 patients) or chemotherapy (134 patients), 376 patients received at least one dose. Overall survival was significantly longer in the blinatumomab group than in the chemotherapy group. The median overall survival was 7.7 months in the blinatumomab group and 4.0 months in the chemotherapy group (hazard ratio for death with blinatumomab...

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Allogeneic Hematopoietic Cell Transplantation for Adult Acute Lymphoblastic Leukemia in the Modern Era.

TL;DR: In this paper , the authors evaluated the characteristics and outcomes of adult ALL patients undergoing allogeneic hematopoietic cell transplantation (HCT) over the last decade and found that transplantation in the later era was more likely to be Hispanic (38% versus 21%) and to have an HCT-comorbidity index ≥3 (31% versus 18%).
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Flow cytometric assessment for minimal/measurable residual disease in B lymphoblastic leukemia/lymphoma in the era of immunotherapy

TL;DR: In this paper , the authors proposed a flow cytometric approach using alternative strategies for population identification, sometimes including alternative gating reagents, have been developed and implemented to monitor MRD in the setting of post targeted therapy.
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Blinatumomab and pancreatitis: an analysis of FAERS, EudraVigilance, and a large urban U.S. patient population data.

TL;DR: Blinatumomab is a bispecific, CD19-directed, CD3 T-cell engaging, antitumor monoclonal antibody approved for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precurso...
References
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Journal ArticleDOI

Chimeric antigen receptor T cells for sustained remissions in leukemia.

TL;DR: Chimeric antigen receptor-modified T-cell therapy against CD19 was effective in treating relapsed and refractory ALL and was associated with a high remission rate, even among patients for whom stem-cell transplantation had failed, and durable remissions up to 24 months were observed.
Journal ArticleDOI

A multiple testing procedure for clinical trials.

TL;DR: The overall size of the procedure is shown to be controlled with virtually the same accuracy as the single sample chi-square test based on N(m1 + m2) observations and the power is found to bevirtually the same.
Journal ArticleDOI

Discrete sequential boundaries for clinical trials

K. K. Gordon Lan, +1 more
- 01 Dec 1983 - 
TL;DR: In this article, the authors proposed a more flexible method to construct discrete sequential boundaries based on the choice of a function, a*(t), which characterizes the rate at which the error level ac is spent.
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