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NCT03092674 · ClinicalTrials.gov registry record · Phase 2

Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
76
Enrollment target

NCT03092674: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT03092674 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT03092674, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
76 participants
Enrollment target

Study Summary

This randomized phase II/III trial studies how well azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone work in treating older patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as azacitidine, decitabine, and cytarabine, 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Midostaurin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone may kill more cancer cells.

Primary Outcome

Time from date of randomization on study until death from any cause with observations censored on the day of last contact for patients not known to have died.

Interventions

  • DRUG Azacitidine
  • DRUG Decitabine
  • OTHER Laboratory Biomarker Analysis
  • DRUG Cytarabine
  • DRUG Midostaurin

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2018-02-02
Est. Completion 2024-06-26
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT03092674 record still lists

NCT03092674 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 5 interventions - of which Azacitidine is the first listed.

NCT03092674 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03092674 about?

NCT03092674 is a clinical study titled "Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome". This randomized phase II/III trial studies how well azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone work in treating older patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as azacitid...

What is the current status of trial NCT03092674?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2018-02-02. Estimated completion is 2024-06-26.

What interventions are being tested in trial NCT03092674?

The interventions under investigation include: Azacitidine (DRUG), Decitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Cytarabine (DRUG), Midostaurin (DRUG).

Who is sponsoring clinical trial NCT03092674?

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

How this trial's enrollment target compares

Where NCT03092674's enrollment target sits among peer trials

76 893rd of 2000 higher than 1,101 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT03092674, the US trial registry maintained by the National Library of Medicine. NCT03092674 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.