Overview
An Investigational Immuno-therapy Study of Ulocuplumab in Combination With Low Dose Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia
Status:
Terminated
Terminated
Trial end date:
2019-06-04
2019-06-04
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bristol-Myers SquibbTreatments:
Antibodies, Monoclonal
Cytarabine
Criteria
For more information regarding BMS clinical trial participation, please visitwww.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