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NCT03953898 · ClinicalTrials.gov registry record · Phase 2
Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation
A Phase 2 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 11
- Study locations
NCT03953898 is a Phase 2 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (88% lower). The trial reports 11 study locations across 6 states.
The verdict
NCT03953898, a Phase 2 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 11
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- DRUG Olaparib
Study Locations (11)
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
North Carolina
- Wake Forest University at Clemmons - Clemmons
- Wake Forest Baptist Health - Wilkes Medical Center - Wilkesboro
- Wake Forest University Health Sciences - Winston-Salem
California
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Connecticut
- Yale University - New Haven
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
New Hampshire
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-08-04 |
| Est. Completion | 2026-02-20 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03953898
The ClinicalTrials.gov registry entry for NCT03953898 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (88% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Biospecimen Collection is the first listed.
NCT03953898 reports 11 study locations spanning 6 distinct geographic areas - top geographies include Florida, North Carolina, California.
Frequently Asked Questions
What is clinical trial NCT03953898 about?
NCT03953898 is a clinical study titled "Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation". 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...
What is the current status of trial NCT03953898?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2020-08-04. Estimated completion is 2026-02-20.
What conditions does trial NCT03953898 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Recurrent Myelodysplastic Syndrome.
What interventions are being tested in trial NCT03953898?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Olaparib (DRUG).
Who is sponsoring clinical trial NCT03953898?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03953898 being conducted?
This trial has 11 study locations across California, Connecticut, Florida, Maryland, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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