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 Center/ Pfitzer. [1]
Study Data
- Condition: Leukemia
- Interventions:
- Phase: I & II
- Estimated Enrollment: 40
- Start: April 2015
- Estimated Primary Completion: April 2020
- Last verified: June 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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