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
• Trial end date: 2018-02-07
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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)