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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: Active Phase 2 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Will be evaluated by Myelodysplastic Syndrome International Working Group (IWG) 2006 criteria (Cheson et al., 2006) and acute myeloid leukemia (AML) IWG 2003 criteria (Cheson et al., 2003) after 6 cycles of treatment. Cumulative ORR will include complete remission (CR), complete remission with incomplete blood count recovery (CRi), partial response (PR), and bone marrow complete remission (marrow CR) achieved at least at one point during these 6 cycles.

Conditions Studied

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

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

FieldValue
Enrollment Target 14 participants
Start Date 2020-08-04
Est. Completion 2026-02-20
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT03953898 still lists

NCT03953898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (88% lower).

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 lists 11 locations in 6 states (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.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03953898's enrollment target sits among peer trials

14 284th of 306 higher than 21 of 306 other Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03953898, the US trial registry maintained by the National Library of Medicine. NCT03953898 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.