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NCT04530565 · ClinicalTrials.gov record · last posted 2026-08-20

Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults

StatusActive, Not Recruiting
PhasePhase 3
Started2021-01-25
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from the ClinicalTrials.gov record
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.

Protocol amendment history 1 change detected by DataLookout

2026-03-31
notable
Trial status changed: Recruiting → Active, Not Recruiting
Trial Details
NCT Number NCT04530565
Lead Sponsor National Cancer Institute (NCI)
Conditions B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Enrollment 348 participants
Start Date 2021-01-25
Primary Completion 2028-07-01 (estimated)
Study Completion 2028-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-20