Study #2020-0133
A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults With Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)
MD Anderson Study Status
Enrolling
Treatment Agent
Blinatumomab
Description
The Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. The Phase II part of the study will evaluate the safety, efficacy, and tolerability of SC blinatumomab for treatment of R/R B-ALL and Minimum Residual Disease Positive (MRD+) B-ALL in participants 12 years old and greater. It will also conduct a clinical pharmacokinetic (PK) evaluation of SC1 and SC2 blinatumomab formulations.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
B Cell Precursor Acute Lymphoblastic Leukemia
Study phase:
Physician name:
Elias Jabbour
Department:
Leukemia
For general questions about clinical trials:
1-877-632-6789
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