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)
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