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Brief Title Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia
Official Title AML08: A Phase II Randomized Trial of Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Phase II Study Of Natural Killer Cell Transplantation In Patients With Newly Diagnosed Acute Myeloid Leukemia
Principal Investigator McNeer, Jennifer
Brief Summary The purpose of this study is to assess the feasibility and efficacy of a novel form of therapy—haploidentical NK cell transplantation—in patients with standard-risk AML. In addition, we will investigate the efficacy of clofarabine + cytarabine (Clo/AraC) in newly diagnosed patients with AML and attempt to optimize outcome through the use of MRD-adapted therapy and further improvements in supportive care.
Gender Both
Ages N/A
Enrollment 270
Accepts Healthy Volunteers No
Lead Sponsor St. Jude Children's Research HospitalOther
Collaborator Genzyme, a Sanofi CompanyIndustry
Study Design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 3
Study Type Interventional
Contact Name Gary Dahl, MD
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Acute Myeloid Leukemia
Detail for Health Professional (on clinicaltrials.gov)
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