NCT01363297 (Clinical Trial / Inotuzumab ozogamycin / CMC-544)

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)
  • Phase: II
  • Estimated Enrollment: 72
  • Start: August 2011
  • Estimated Completion: February 2016
  • Last verified: May 2015

Study Schematic 

NCT01363297 (Clinical Trial / Inotuzumab ozogamycin / CMC-544)

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Last Editorial review: July 31, 2016
Information based on (NIH/NCI) and other sources.

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