Lymphoblastic Leukemia, Acute T-cell, Precursor T-Cell Lymphoblastic Lymphoma
Conditions
Brief summary
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
Detailed description
Minimum Age: 10 years and older at selected sites
Interventions
DRUGBMS-906024
DRUGDexamethasone
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events as a measure of safety and tolerability | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: maximum observed concentration (Cmax) | Pharmacokinetics at multiple time points during the first 4 weeks of dosing |
| Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: minimum observed concentration (Cmin) | Pharmacokinetics at multiple time points during the first 4 weeks of dosing |
| Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: area under the concentration-time curve (AUC) | Pharmacokinetics at multiple time points during the first 4 weeks of dosing |
| Disease assessments in bone marrow & by computed tomography (CT)/ magnetic resonance imaging (MRI) | Disease assessments at least every 8 weeks during treatment |
| Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: terminal phase elimination half-life (T-Half) | Pharmacokinetics at multiple time points during the first 4 weeks of dosing |
| Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: accumulation index (ratio of AUC at steady state to AUC after first dose) | Pharmacokinetics at multiple time points during the first 4 weeks of dosing |
| Pharmacodynamics (percent change from baseline in mRNA expression of Notch pathway-related genes in blood cells) | Pharmacodynamic sampling: in blood during the first 8 weeks of dosing |
| Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: time to reach maximum observed concentration (Tmax) | Pharmacokinetics at multiple time points during the first 4 weeks of dosing |
Countries
France, Germany, United States
Outcome results
None listed