Lymphoblastic Leukemia, Acute T-cell Clinical Trial
Official title:
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
| Verified date | July 2019 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | February 7, 2018 |
| Est. primary completion date | February 7, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| France | Local Institution | Marseille Cedex 9 | |
| France | Local Institution | Paris Cedex 10 | |
| Germany | Johann Wolfgang Goethe Universitaet | Frankfurt/main | |
| United States | Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | The University Of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, France, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Disease assessments in bone marrow & by computed tomography (CT)/ magnetic resonance imaging (MRI) | Disease assessments at least every 8 weeks during treatment | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 |