NCT01363297

Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

An Open-label, Phase 1/2 Study Of Inotuzumab Ozogamicin In Subjects With Relapsed Or Refractory Cd22-positive Acute Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Inotuzumab Ozogamicin	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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-08-01
• Completion: 2016-01-01
• First posted: 2011-06-01
• Last updated: 2017-04-13
• Results posted: 2017-04-13

Locations

15 sites across 1 country: United States