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

Stopped early · Phase 1/Phase 2

Conditions studied: Leukemia

In brief

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).

Key facts

Study ID

NCT02305563

Run by

Bristol-Myers Squibb

People needed

70

Starts

2015-01-27

Expected to finish

2019-06-04

Last updated by the study team

2021-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly Diagnosed Acute Myeloid Leukemia (AML)
• Considered inappropriate for intensive remission induction therapy by an investigator
• Not eligible for stem cell transplantation

You may not qualify if…

• 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

Where it is running

• 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 — Naples, Italy
• Local Institution — Roma, Italy
• Local Institution — Nagoya, Aichi-ken, Japan
• Local Institution — Fukuyama-shi, Hiroshima, Japan

Full record on ClinicalTrials.gov

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