At a glance
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A Feasibility Trial of MLN4924 (Pevonedistat, TAK 924) Given in Combination With Azacitidine, Fludarabine, and Cytarabine, in Children, Adolescents, and Young Adults With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
In Brief
A Phase 1 clinical trial evaluating Azacitidine, Cytarabine, and 4 other interventions for Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and 4 related conditions. Completed, enrolled 12 participants across 19 sites.
Detailed Summary
This phase I trial studies the side effects and how well pevonedistat, azacitidine, fludarabine phosphate, and cytarabine work in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back (relapsed) or has not responded to treatment (refractory). Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as azacitidine, fludarabine phosphate, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and pevonedistat may work better in treating patients with acute myeloid leukemia or myelodysplastic syndrome.
Study Details
Timeline
Interventions
Given IV
Given intrathecally and IV
Given IV
Given intrathecally
Given IV
Given intrathecally