Study to Evaluate the Safety and Tolerability of Weekly Intravenous (IV) Doses of BMS-906024 in Subjects With Acute T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Completed · Phase 1
Conditions studied: Lymphoblastic Leukemia, Acute T-cell, Precursor T-Cell Lymphoblastic Lymphoma
In brief
The purpose of this study is to identify a safe and tolerable dose of BMS-906024, either alone or in combination with Dexamethasone in subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma who no longer respond to or have relapsed from standard therapies
Key facts
- Study ID
- NCT01363817
- Run by
- Bristol-Myers Squibb
- People needed
- 31
- Starts
- 2011-09-28
- Expected to finish
- 2018-02-07
- Last updated by the study team
- 2019-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma refractory to or relapsed from standard therapies
- Life expectancy of at least 2 months
- Performance status (PS) 0-1 (a measure of the ability to carry out activities of daily living); subjects with PS 2 are eligible if due to disease related symptoms
- Prior anti-cancer treatment permitted (with specific criteria)
- Adequate organ function
You may not qualify if…
- Infection
- Elevated triglycerides
- Gastro-intestinal disease with increased risk of diarrhea (e.g. inflammatory bowel disease)
- Unable to tolerate bone marrow biopsy
- Taking medications known to increase risk of Torsades De Pointes (an abnormal heart rhythm)
Where it is running
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- The University Of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Local Institution — Marseille, France
- Local Institution — Paris, France
- Johann Wolfgang Goethe Universitaet — Frankfurt am Main, Germany
Full record on ClinicalTrials.gov
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