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 Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Precursor T-Cell Lymphoblastic Lymphoma; Lymphoblastic Leukemia, Acute T-cell

Treatments: Drug: BMS-906024; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01363817

2010-022727-29 (EudraCT Number)

CA216-002

Details and patient eligibility

About

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

Full description

Minimum Age: 10 years and older at selected sites

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Escalation Phase: BMS-906024

Experimental group

Description:

BMS-906024 escalating doses starting at 0.3 mg solution for intravenous (IV) administration once weekly continuously until disease progression or unacceptable toxicity

Treatment:

Drug: BMS-906024

Expansion Phase: BMS-906024 + Dexamethasone

Experimental group

Description:

BMS-906024 maximum tolerated dose (To be determined) solution for IV administration once weekly and Dexamethasone 20mg/day tablet by mouth (Oral) for 3-4 days every week for 3-4 weeks per cycle continuously until disease progression or unacceptable toxicity

Treatment:

Drug: Dexamethasone

Drug: BMS-906024