OncoMatch/Clinical Trials/NCT04521231
A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL
Is NCT04521231 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Blinatumomab for b cell precursor acute lymphoblastic leukemia.
Treatment: Blinatumomab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Allowed: BCR fusion
Any Ph+ participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.
Allowed: CD19 positive expression
Prior failed cluster of differentiation (CD19) directed therapy such as prior blinatumomab or CD19 CAR T cells will be allowed (with demonstrated continued CD19+ expression)
Prior therapy
Cannot have received: allogeneic hematopoietic stem cell transplant
Allogeneic HSCT within 12 weeks before the start of protocol-specified therapy
Cannot have received: cancer chemotherapy
Exception: with certain exceptions
Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy (with certain exceptions)
Cannot have received: immunotherapy
Immunotherapy within 4 weeks before start of protocol-specified therapy
Cannot have received: investigational therapy
Currently receiving treatment in or less than 30 days or 5 half-lives since ending treatment on another investigational study(ies)
Lab requirements
Blood counts
Ph-IIM: ANC ≥ 500/μL; Platelet count ≥ 50,000/μL (transfusion permitted); Hemoglobin level ≥ 9 g/dL (transfusion permitted)
Ph-IIM: BM function as follows: ANC ≥ 500/μL; Platelet count ≥ 50,000/μL (transfusion permitted); Hemoglobin level ≥ 9 g/dL (transfusion permitted)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope National Medical Center · Duarte, California
- University of Illinois Chicago · Chicago, Illinois
- Johns Hopkins University · Baltimore, Maryland
- C.S. Mott Children's Hospital - University of Michigan · Ann Arbor, Michigan
- New York University Grossman School of Medicine and New York University Langone Hospitals · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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