At a glance
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The PRIME Trial: PARP Inhibition in IDH Mutant Effectiveness Trial. A Phase II Study of Olaparib in Isocitrate Dehydrogenase (IDH) Mutant Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome
In Brief
A Phase 2 clinical trial evaluating Biospecimen Collection, Bone Marrow Aspiration, and 1 other intervention for Acute Myeloid Leukemia and 6 related conditions. Active but no longer recruiting, targeting 14 participants across 11 sites.
Signals
Detailed Summary
This phase II trial studies how well olaparib works in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory), or myelodysplastic syndrome. Patients must also have a change in the gene called the IDH gene (IDH mutation). Olaparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Study Details
Timeline
Arms & Interventions
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity, or absence of remission after 6 cycles for patients without prior exposure to IDH inhibitors. Patients also undergo bone marrow aspiration and collection of blood throughout the study.
Interventions
Undergo collection of blood
Undergo bone marrow aspiration
Given PO