Conditions: Acute Lymphocytic Leukemia
Keywords: Relapsed/Refractory Acute Lymphocytic Leukemia (ALL)
Enrollment: 72
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Inotuzumab Ozogamicin
Intervention descriptions: intervention 1: Part 1: Administered intravenously as 2 - 3 weekly doses over a 28-day cycle for a maximum of 6 cycles. Total dose per cycle 0.8 mg/m\^2 to 2.0 mg/m\^2.

Part 2 Expansion and Part 3 Phase 2: Administered intravenously as 3 weekly doses over a 28-day cycle for a maximum of 6 cycles. Total initial dose per cycle 1.8 mg/m\^2.

Protocol document: