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

Bristol-Myers Squibb31 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoblastic Leukemia, Acute T-cell Precursor T-Cell Lymphoblastic Lymphoma

Interventions

BMS-906024DRUG

DexamethasoneDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (6)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The University Of Texas MD Anderson Cancer Center

Houston, Texas, United States

Local Institution

Marseille, France

Outcomes

Primary Outcomes

Number of subjects with adverse events as a measure of safety and tolerability

Time frame: Weekly assessments until study discontinuation due to disease progression or unacceptable adverse events as well as an assessment 30 days after treatment discontinuation with an average time on study expected to be < 1 year.