Study Title
Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia (NCT01363297)
Trial Description
The Phase 1 portion of this study will assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin (also known as CMC-544) 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.
This trial is sponsored by UCB Pharma/ Pfitzer. [1]
Study Data
- Condition: Leukemia
- Interventions:
- Drugs used in this trial
- Inotuzumab Ozogamicin (CMC-544)
- Drugs used in this trial
- Phase: II
- Estimated Enrollment: 72
- Start: August 2011
- Estimated Completion: February 2016
- Last verified: May 2015
Study Schematic
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Last Editorial review: July 31, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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