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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02305563
Recruitment Status : Terminated (Business objectives have changed, slow accrual, the standard of care for the patient population changed and we were unable to accrue any longer.)
First Posted : December 2, 2014
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Leukemia Drug: BMS-936564 Drug: Cytarabine Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 27, 2015
Actual Primary Completion Date : June 4, 2019
Actual Study Completion Date : June 4, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Cytarabine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ulocuplumab + low dose Cytarabine
Ulocuplumab + low dose Cytarabine (LDAC) Phase 1 (escalation cohort) - closed for enrollment
 Drug: BMS-936564
Other Names:
  • Ulocuplumab
  • MDX-1338

Drug: Cytarabine
Experimental: Ulocuplumab Dose A + low dose Cytarabine
Ulocuplumab Dose A + low dose Cytarabine Phase 2 (expansion cohort)
 Drug: BMS-936564
Other Names:
  • Ulocuplumab
  • MDX-1338

Drug: Cytarabine
Experimental: Ulocuplumab Dose B + low dose Cytarabine
Ulocuplumab Dose B + low dose Cytarabine Phase 2 (expansion cohort)
 Drug: BMS-936564
Other Names:
  • Ulocuplumab
  • MDX-1338

Drug: Cytarabine
low dose Cytarabine only
Low Dose Cytarabine only Phase 2 (expansion cohort)
 Drug: BMS-936564
Other Names:
  • Ulocuplumab
  • MDX-1338

Drug: Cytarabine


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Phase 1 (escalation cohort)

  2. Number of Adverse Events (AEs) [ Time Frame: Up to 30 days after discontinuation of treatment ]
    Phase 1 (escalation cohort)

  3. Number of Grade 3 or higher Adverse Events (AEs) [ Time Frame: Up to 30 days after discontinuation of treatment ]
    Phase 1 (escalation cohort)

  4. Number of Adverse Events (AEs) leading to discontinuation [ Time Frame: Up to 30 days after discontinuation of treatment ]
    Phase 1 (escalation cohort)

  5. Number of Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days after discontinuation of treatment ]
    Phase 1 (escalation cohort)

  6. Number of Adverse Events (AEs) leading to death [ Time Frame: Up to 30 days after discontinuation of treatment ]
    Phase 1 (escalation cohort)

  7. Number of Laboratory Abnormalities [ Time Frame: Up to 30 days after discontinuation of treatment ]
    Phase 1 (escalation cohort)

  8. Overall response based on the Rate of Complete Remission (CR/CRi) [ Time Frame: Up to 30 days after discontinuation of treatment ]
    Phase 2 (expansion cohort) Complete Remission (CR), Complete Remission with incomplete blood count recovery (CRi), Rate of Complete Remission (CR/CRi)


Secondary Outcome Measures :
  1. Investigator assessed best overall response(BOR) using AML response criteria [ Time Frame: Up to 30 days after discontinuation of treatment ]
    Phase 1 (escalation cohort)

  2. Number of Adverse Events (AEs) [ Time Frame: Up to 30 days after discontinuation of treatment ]
    Phase 2 (expansion cohort)

  3. Number of Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days after discontinuation of treatment ]
    Phase 2 (expansion cohort)

  4. Number of Adverse Events (AEs) leading to discontinuation [ Time Frame: Up to 30 days after discontinuation of treatment ]
    Phase 2 (expansion cohort)

  5. Number of Adverse Events (AEs) leading to death [ Time Frame: Up to 30 days after discontinuation of treatment ]
    Phase 2 (expansion cohort)

  6. Number of Laboratory Abnormalities [ Time Frame: Up to 30 days after discontinuation of treatment ]
    Phase 2 (expansion cohort)

  7. anti-drug antibody(ADA) positive for ulocuplumab [ Time Frame: Up to 30 days after discontinuation of treatment ]
  8. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 30 days after discontinuation of treatment ]
  9. Trough observed serum concentration (Ctrough) [ Time Frame: Up to 30 days after discontinuation of treatment ]
  10. Time of maximum observed ulocuplumab serum concentration (Tmax) [ Time Frame: Up to 30 days after discontinuation of treatment ]
  11. 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 ]
  12. Area under the ulocuplumab concentration-time curve in one dosing interval (AUC{TAU}) [ Time Frame: Up to 30 days after discontinuation of treatment ]
  13. Area under the ulocuplumab concentration-time curve from time zero to infinity (AUC(INF)) [ Time Frame: Up to 30 days after discontinuation of treatment ]
  14. Elimination half life (T-HALF) [ Time Frame: Up to 30 days after discontinuation of treatment ]
  15. Total body clearance (CLT) of ulocuplumab [ Time Frame: Up to 30 days after discontinuation of treatment ]
  16. Volume of distribution at steady state (Vss) [ Time Frame: Up to 30 days after discontinuation of treatment ]
  17. Change from Baseline in electrocardiogram(ECG) intervals [ Time Frame: Baseline up to 30 days after discontinuation of treatment ]
  18. Overall Remission (OR) as determined by investigator assessment using AML response criteria [ Time Frame: Up to 30 days after discontinuation of treatment ]
  19. 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 ]
    Complete Remission (CR), Complete Remission with incomplete blood count recovery (CRi)

  20. Overall Survival (OS) [ Time Frame: Up to 2 years ]
    Overall survival: Defined as the time between the date of randomization and the date of death due to any cause


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305563


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02305563    
Other Study ID Numbers: CA212-016
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs