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

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

sites

University of Texas M.D. Anderson Cancer Center

1515 Holcombe Blvd
Houston, Texas 77030

713-792-2121