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An Investigational Immuno-therapy Study of Ulocuplumab in Combination With Low Dose Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT02305563

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).

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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

  • Leukemia

Interventions

DrugSynonymsArms
BMS-936564Ulocuplumab, MDX-1338Ulocuplumab + low dose Cytarabine
CytarabineUlocuplumab + 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

NameTypeDescriptionInterventions
Ulocuplumab + low dose CytarabineExperimentalUlocuplumab + low dose Cytarabine (LDAC) Phase 1 (escalation cohort) - closed for enrollment
  • BMS-936564
  • Cytarabine
Ulocuplumab Dose A + low dose CytarabineExperimentalUlocuplumab Dose A + low dose Cytarabine Phase 2 (expansion cohort)
  • BMS-936564
  • Cytarabine
Ulocuplumab Dose B + low dose CytarabineExperimentalUlocuplumab Dose B + low dose Cytarabine Phase 2 (expansion cohort)
  • BMS-936564
  • Cytarabine
low dose Cytarabine onlyOtherLow Dose Cytarabine only Phase 2 (expansion cohort)
  • BMS-936564
  • Cytarabine

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:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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