drugset
drugset / Trial / NCT03962465

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

NCT03962465 ↗

Phase 1 Active not recruiting 36 enrolled University of Virginia Pfizer · collabUniversity of Wisconsin, Madison · collabVanderbilt University · collabVirginia Commonwealth University · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-07-22
Primary completion
2023-07-15
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Inotuzumab Ozogamicin Monoclonal antibody 0.4 mg/m2 Intravenous
Subject Inotuzumab Ozogamicin Monoclonal antibody 0.9 mg/m2 Intravenous
Subject Pegaspargase Protein / enzyme biologic — Intravenous
Background Cytarabine Small molecule — Other
Background Daunorubicin Small molecule — Intravenous
Background Methotrexate Small molecule — Other
Background Prednisone Other / unclassified — Oral
Background Vincristine Small molecule — Intravenous

Indications

B-cell acute lymphoblastic leukemia