Description:
The purpose of this study is to determine the safety and effectiveness of ulocuplumab in
combination with low dose cytarabine in the treatment of Newly Diagnosed Acute Myeloid
Leukemia (AML).
Title
- Brief Title: An Investigational Immuno-therapy Study of Ulocuplumab in Combination With Low Dose Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia
- Official Title: A Phase 1/2, Open-label Randomized Study of Ulocuplumab (BMS-936564) in Combination With Low Dose Cytarabine in Subjects With Newly Diagnosed Acute Myeloid Leukemia
Clinical Trial IDs
- ORG STUDY ID:
CA212-016
- NCT ID:
NCT02305563
Conditions
Interventions
Drug | Synonyms | Arms |
---|
BMS-936564 | Ulocuplumab, MDX-1338 | Ulocuplumab + low dose Cytarabine |
Cytarabine | | Ulocuplumab + low dose Cytarabine |
Purpose
The purpose of this study is to determine the safety and effectiveness of ulocuplumab in
combination with low dose cytarabine in the treatment of Newly Diagnosed Acute Myeloid
Leukemia (AML).
Trial Arms
Name | Type | Description | Interventions |
---|
Ulocuplumab + low dose Cytarabine | Experimental | Ulocuplumab + low dose Cytarabine (LDAC) Phase 1 (escalation cohort) - closed for enrollment | |
Ulocuplumab Dose A + low dose Cytarabine | Experimental | Ulocuplumab Dose A + low dose Cytarabine Phase 2 (expansion cohort) | |
Ulocuplumab Dose B + low dose Cytarabine | Experimental | Ulocuplumab Dose B + low dose Cytarabine Phase 2 (expansion cohort) | |
low dose Cytarabine only | Other | Low Dose Cytarabine only Phase 2 (expansion cohort) | |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Newly Diagnosed Acute Myeloid Leukemia (AML)
- Considered inappropriate for intensive remission induction therapy by an investigator
- Not eligible for stem cell transplantation
Exclusion Criteria:
- Acute promyelocytic leukemia
- Current Myelodysplastic syndrome only subjects
- Unstable angina or uncontrolled congestive heart failure
- Any other malignancy, excluding basal or squamous cell carcinoma of the skin, in situ
melanoma, cervical carcinoma in situ, localized prostate cancer, or superficial
bladder cancer stage 0, from which the subject has not been disease-free for at least
3 years
- Respiratory disease requiring continuous supplemental oxygen
Other protocol defined inclusion/exclusion criteria could apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of patients experiencing a ulocuplumab-related dose limiting toxicity (DLT) during the DLT evaluation period based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | Phase 1 (escalation cohort) |
Secondary Outcome Measures
Measure: | Investigator assessed best overall response(BOR) using AML response criteria |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | Phase 1 (escalation cohort) |
Measure: | Number of Adverse Events (AEs) |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | Phase 2 (expansion cohort) |
Measure: | Number of Serious Adverse Events (SAEs) |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | Phase 2 (expansion cohort) |
Measure: | Number of Adverse Events (AEs) leading to discontinuation |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | Phase 2 (expansion cohort) |
Measure: | Number of Adverse Events (AEs) leading to death |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | Phase 2 (expansion cohort) |
Measure: | Number of Laboratory Abnormalities |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | Phase 2 (expansion cohort) |
Measure: | anti-drug antibody(ADA) positive for ulocuplumab |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | |
Measure: | Maximum observed serum concentration (Cmax) |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | |
Measure: | Trough observed serum concentration (Ctrough) |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | |
Measure: | Time of maximum observed ulocuplumab serum concentration (Tmax) |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | |
Measure: | Area under the ulocuplumab concentration-time curve from time zero to the last quantifiable concentration (AUC(0-T)) |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | |
Measure: | Area under the ulocuplumab concentration-time curve in one dosing interval (AUC{TAU}) |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | |
Measure: | Area under the ulocuplumab concentration-time curve from time zero to infinity (AUC(INF)) |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | |
Measure: | Elimination half life (T-HALF) |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | |
Measure: | Total body clearance (CLT) of ulocuplumab |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | |
Measure: | Volume of distribution at steady state (Vss) |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | |
Measure: | Change from Baseline in electrocardiogram(ECG) intervals |
Time Frame: | Baseline up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | |
Measure: | Overall Remission (OR) as determined by investigator assessment using AML response criteria |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | |
Measure: | Duration of complete Remission (CR/CRi) as determined by investigator assessment using AML response criteria |
Time Frame: | Up to 30 days after discontinuation of treatment |
Safety Issue: | |
Description: | Complete Remission (CR), Complete Remission with incomplete blood count recovery (CRi) |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | Overall survival: Defined as the time between the date of randomization and the date of death due to any cause |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
May 13, 2020