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
Status: | Completed |
---|---|
Conditions: | Blood Cancer, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/2/2018 |
Start Date: | September 28, 2011 |
End Date: | February 7, 2018 |
Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
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
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
Minimum Age: 10 years and older at selected sites
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
We found this trial at
4
sites
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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