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

Part of paid clinical trials in Orange, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03953898
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
  • Acute Myeloid Leukemia Post Cytotoxic Therapy
  • Recurrent Acute Myeloid Leukemia
  • Recurrent Myelodysplastic Syndrome
  • Refractory Acute Myeloid Leukemia
  • Refractory Myelodysplastic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Olaparib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Aug 4, 2020
Status verified
Mar 2026
Primary completion
Jan 16, 2024
Completion
Mar 4, 2027

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (olaparib)
    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.

Primary Outcome Measure

Cumulative Overall Response Rate (ORR) [ Time Frame: Up to 6 cycles ]

Locations (11)

FacilityCityStateZIPSite coordinators
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
Yale UniversityNew HavenConnecticut06520-
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146-
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
UM Sylvester Comprehensive Cancer Center at PlantationPlantationFlorida33324-
University of Maryland/Greenebaum Cancer CenterBaltimoreMaryland21201-
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanonNew Hampshire03756-
Wake Forest University at ClemmonsClemmonsNorth Carolina27012-
Wake Forest Baptist Health - Wilkes Medical CenterWilkesboroNorth Carolina28659-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-

Find similar trials in Orange, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
UC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAYale University· New Haven, CTUM Sylvester Comprehensive Cancer Center at Coral Gables· Coral Gables, FLUM Sylvester Comprehensive Cancer Center at Deerfield Beach· Deerfield Beach, FLUniversity of Miami Miller School of Medicine-Sylvester Cancer Center· Miami, FLUM Sylvester Comprehensive Cancer Center at Plantation· Plantation, FL

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