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

Local Institution

Marseille Cedex 9, 13273

from

Marseille Cedex 9,