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Clinical Trial Details

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Brief Title An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Subjects With Acute Myeloid Leukemia (AML)
Official Title A Randomized, Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 Years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)
Principal Investigator Odenike, Olatoyosi
Brief Summary This is a Phase 2, multicenter, randomized, parallel-group, open-label study consisting of 3 phases: Screening, Treatment, and Follow-up. To confirm the safety, ie, the absence of overlapping toxicities of the combination treatment regimen, an early safety monitoring will be performed based on approximately the first 12 subjects randomized. A total of approximately 72 subjects will be included in the Myelodysplastic syndromes (MDS) cohort and approximately 110 subjects in the Acute Myeloid Leukemia (AML) cohort.
Gender All
Ages 18 Years
Enrollment 182
Accepts Healthy Volunteers No
Lead Sponsor CelgeneIndustry
Collaborator
Study Design
Study Phase Phase 2
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Leukemia, Myeloid, Acute
Detail for Health Professional (on clinicaltrials.gov)
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