Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Younger Adults With Relapsed/Refractory B-cell ALL
Status:
Recruiting
Trial end date:
2025-11-30
Target enrollment:
Participant gender:
Summary
In the proposed study, escalating doses of inotuzumab ozogamicin will be added to a standard
pediatric inspired re-induction regimen and administered to younger adults 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.
Phase:
Phase 1
Details
Lead Sponsor:
University of Virginia
Collaborators:
Pfizer University of Wisconsin, Madison Vanderbilt University Virginia Commonwealth University