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NCT02890329 · ClinicalTrials.gov registry record · Phase 1

Ipilimumab and Decitabine in Treating Patients With Relapsed or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia

A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
54
Enrollment target
11
Study locations

NCT02890329: Active Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).

NCT02890329 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 54 participants, above the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (15% higher). The trial reports 11 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02890329, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
54 participants
Enrollment target
11
Study locations

Study Summary

This phase I trial studies the side effects and best dose of ipilimumab when given together with decitabine in treating patients with myelodysplastic syndrome or acute myeloid leukemia that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ipilimumab and decitabine may work better in treating patients with relapsed or refractory myelodysplastic syndrome or acute myeloid leukemia.

Primary Outcome

Defined as the highest dose at which 1 or fewer of 6 patients experience a dose limiting toxicity graded by Common Terminology Criteria for Adverse Events version 5.0 criteria.

Conditions Studied

Refractory Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia Recurrent Myelodysplastic Syndrome Secondary Acute Myeloid Leukemia Refractory Myelodysplastic Syndrome Previously Treated Myelodysplastic Syndrome Secondary Myelodysplastic Syndrome Recurrent Acute Myeloid Leukemia, Myelodysplasia-Related

Interventions

  • DRUG Decitabine
  • BIOLOGICAL Ipilimumab

Study Locations (11)

Massachusetts

  • Massachusetts General Hospital Cancer Center - Boston
  • Brigham and Women's Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston
  • Dana-Farber Cancer Institute - Boston

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • UC San Diego Moores Cancer Center - La Jolla
  • University of California Davis Comprehensive Cancer Center - Sacramento

Florida

  • Moffitt Cancer Center - Tampa

Georgia

  • Northside Hospital - Atlanta

Ohio

  • Case Western Reserve University - Cleveland

Virginia

  • University of Virginia Cancer Center - Charlottesville

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2017-09-05
Est. Completion 2026-08-19
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT02890329 still lists

NCT02890329 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, above the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (15% higher).

The record links to 8 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Decitabine is the first listed.

NCT02890329 lists 11 locations in 6 states (Massachusetts, California, Florida).

Frequently Asked Questions

What is clinical trial NCT02890329 about?

NCT02890329 is a clinical study titled "Ipilimumab and Decitabine in Treating Patients With Relapsed or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia". This phase I trial studies the side effects and best dose of ipilimumab when given together with decitabine in treating patients with myelodysplastic syndrome or acute myeloid leukemia that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Immunothe...

What is the current status of trial NCT02890329?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2017-09-05. Estimated completion is 2026-08-19.

What conditions does trial NCT02890329 study?

This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome, Secondary Acute Myeloid Leukemia, Refractory Myelodysplastic Syndrome.

What interventions are being tested in trial NCT02890329?

The interventions under investigation include: Decitabine (DRUG), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT02890329?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02890329 being conducted?

This trial has 11 study locations across California, Florida, Georgia, Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Refractory 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 NCT02890329's enrollment target sits among peer trials

54 18th of 63 higher than 44 of 63 other Refractory Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Refractory 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 NCT02890329, the US trial registry maintained by the National Library of Medicine. NCT02890329 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.