Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
The Phase 1 portion of this study will assess the safety, tolerability and efficacy at
increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or
refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2
dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of
inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in
second or later salvage status.