Clinical Trial

Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL

Study acronym: ALL-001
Unknown Phase 1
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Summary
In the proposed study, escalating doses of inotuzumab ozogamicin will be added to a standard pediatric inspired re-induction regimen and administered to patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). Two re-induction regimens will be tested (one without pegaspargase and one including pegaspargase) and participants will be followed for disease status, allogeneic hematopoietic cell transplant (allo HCT), veno-occlusive disease following allo HCT, and overall survival.
Protocol Amendment History 1 change
critical Trial status changed: Active, Not Recruiting → Unknown 2026-08-09
Trial Details
NCT Number NCT03962465
Lead Sponsor University of Virginia
Collaborators: Pfizer, Vanderbilt University, University of Wisconsin, Madison, Virginia Commonwealth University
Conditions B-cell Acute Lymphoblastic Leukemia
Enrollment 36 participants
Start Date 2022-07-22
Primary Completion 2023-07-15 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2023-08-22