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NCT02311998 (Clinical Trial / inotuzumab ozogamycin / CMC-544)

Study Title
Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive Philadelphia-Chromosome (PC) Positive Acute Lymphoblastic Leukemia (ALL) and Chronic Myeloid Leukemia (CML) (NCT02311998)

Trial Description
There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion).

The goal of Part 1 of this clinical research study is to find the highest tolerable dose of the combination of bosutinib and inotuzumab ozogamicin (also known as CMC-544) that can be given to patients with Ph+ ALL and CML in the lymphoid blast phase that also expresses CD22.

The goal of Part 2 is to learn if the dose found in Part 1 can help to control the disease.

The safety of this drug combination will also be studied.

This trial is sponsored by the M.D. Anderson Cancer CenterPfitzer. [1]

Study Data

  • Condition: Leukemia
  • Interventions:
    • Drugs used in this trial
      • Bosutinib (Bosulif®; Pfizer/Wyeth-Ayerst Laboratories)
      • Inotuzumab Ozogamicin (CMC-544)
    • Behavioral: Phone Call
  • Phase: I & II
  • Estimated Enrollment: 40
  • Start: April 2015
  • Estimated Primary Completion: April 2020
  • Last verified: June 2015

Study Schematic 

NCT02311998 (Clinical Trial / inotuzumab ozogamycin / CMC-544)

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

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