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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-28

Study Completion Date

2018-02-07

Brief Summary

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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

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Detailed Description

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Minimum Age: 10 years and older at selected sites

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Escalation Phase: BMS-906024

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

Group Type EXPERIMENTAL

BMS-906024

Intervention Type DRUG

Expansion Phase: BMS-906024 + Dexamethasone

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

Group Type EXPERIMENTAL

BMS-906024

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Interventions

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BMS-906024

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Other Intervention Names

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Notch inhibitor Baycadron

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No