Status:
TERMINATED
An Investigational Immuno-therapy Study of Ulocuplumab in Combination With Low Dose Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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).
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- Newly Diagnosed Acute Myeloid Leukemia (AML)
- Considered inappropriate for intensive remission induction therapy by an investigator
- Not eligible for stem cell transplantation
Exclusion
- 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
Key Trial Info
Start Date :
January 27 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02305563
Start Date
January 27 2015
End Date
June 4 2019
Last Update
September 16 2021
Active Locations (38)
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1
Ucla Center Health Sci
Los Angeles, California, United States, 90095-3075
2
UF Health Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
3
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
4
NYU Langone Medical Center
New York, New York, United States, 10016