An Investigational Immuno-therapy Study of Ulocuplumab in Combination With Low Dose Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT ID: NCT02305563
Last Updated: 2021-09-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
70 participants
INTERVENTIONAL
2015-01-27
2019-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ulocuplumab + low dose Cytarabine
Ulocuplumab + low dose Cytarabine (LDAC) Phase 1 (escalation cohort) - closed for enrollment
BMS-936564
Cytarabine
Ulocuplumab Dose A + low dose Cytarabine
Ulocuplumab Dose A + low dose Cytarabine Phase 2 (expansion cohort)
BMS-936564
Cytarabine
Ulocuplumab Dose B + low dose Cytarabine
Ulocuplumab Dose B + low dose Cytarabine Phase 2 (expansion cohort)
BMS-936564
Cytarabine
low dose Cytarabine only
Low Dose Cytarabine only Phase 2 (expansion cohort)
BMS-936564
Cytarabine
Interventions
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BMS-936564
Cytarabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Considered inappropriate for intensive remission induction therapy by an investigator
* Not eligible for stem cell transplantation
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Ucla Center Health Sci
Los Angeles, California, United States
UF Health Cancer Center at Orlando Health
Orlando, Florida, United States
Norton Cancer Institute
Louisville, Kentucky, United States
NYU Langone Medical Center
New York, New York, United States
Duke University Adult Bone Marrow Transplant Clinic
Durham, North Carolina, United States
University Of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
The University Of Texas MD Anderson Cancer Center
Houston, Texas, United States
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Liga Paranaense De Combate Ao Cancer Erasto Gaertner
Curitiba, Paraná, Brazil
Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Pio Xii Hosp Cancer De Barretos
Barretos, São Paulo, Brazil
IEP Sao Lucas
São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
Halifax, Nova Scotia, Canada
Local Institution
Hong Kong, , China
Local Institution
Jerusalem, , Israel
Local Institution
Tel Aviv, , Israel
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, , Italy
Local Institution
Milan, , Italy
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
Napoli, , Italy
Local Institution
Roma, , Italy
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Fukuyama-shi, Hiroshima, Japan
Local Institution
Isehara, Kanagawa, Japan
Local Institution
Hirakata-shi, Osaka, Japan
Local Institution
Bunkyo-ku, Tokyo, Japan
Local Institution
Shinagawa-ku, Tokyo, Japan
Local Institution
Shinjuku-Ku, Tokyo, Japan
Local Institution
Tachikawa, Tokyo, Japan
Local Institution
Bucharest, , Romania
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Kaohsiung City, , Taiwan
Local Institution
New Taipei City, , Taiwan
Local Institution
New Taipei City, , Taiwan
Local Institution
Taoyuan, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CA212-016
Identifier Type: -
Identifier Source: org_study_id
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