๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-12

Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation (NCT03953898)

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

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: UC Irvine Health/Chao Family Comprehensive Cancer Center โ€” Orange, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (11 Sites)

  • UC Irvine Health/Chao Family Comprehensive Cancer Center โ€” Orange, California
  • Yale University โ€” New Haven, Connecticut
  • UM Sylvester Comprehensive Cancer Center at Coral Gables โ€” Coral Gables, Florida
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach โ€” Deerfield Beach, Florida
  • University of Miami Miller School of Medicine-Sylvester Cancer Center โ€” Miami, Florida
  • UM Sylvester Comprehensive Cancer Center at Plantation โ€” Plantation, Florida
  • University of Maryland/Greenebaum Cancer Center โ€” Baltimore, Maryland
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center โ€” Lebanon, New Hampshire
  • Wake Forest University at Clemmons โ€” Clemmons, North Carolina
  • Wake Forest Baptist Health - Wilkes Medical Center โ€” Wilkesboro, North Carolina
  • Wake Forest University Health Sciences โ€” Winston-Salem, North Carolina

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—