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: Recruiting
Phase: Phase 1
Diagnosis: Leukemia/MDS, Non-Hodgkin's Lymphoma
NCT ID: NCT01363817
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-290
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
Conducting Institutions:
Dana-Farber Cancer Institute
Overall PI:
Daniel DeAngelo, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Ilene Galinsky, 617-632-3902,
igalinsky@partners.org
Eligibility Criteria
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)