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NCT03724084 · ClinicalTrials.gov registry record · Phase 1

Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Terminated
Registry status
Phase 1
Development phase
6
Enrollment target

NCT03724084: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT03724084 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03724084, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).

TERMINATED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study Summary

This phase Ib/II trial studies the side effects and best dose of pinometostat and how well it works with standard chemotherapy in treating patients with newly diagnosed acute myeloid leukemia and a type of genetic mutation called MLL gene rearrangement. Pinometostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in standard chemotherapy, such as daunorubicin hydrochloride 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. Giving pinometostat with standard chemotherapy may work better at treating acute myeloid leukemia.

Primary Outcome

Dose escalation for phase 1b will be in the usual 3+3 fashion

Interventions

  • DRUG Cytarabine
  • DRUG Daunorubicin
  • DRUG Daunorubicin Hydrochloride
  • DRUG Pinometostat

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2019-04-10
Est. Completion 2022-11-14
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

Why NCT03724084 stopped before completion

NCT03724084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 4 interventions - of which Cytarabine is the first listed.

NCT03724084 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03724084 about?

NCT03724084 is a clinical study titled "Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement". This phase Ib/II trial studies the side effects and best dose of pinometostat and how well it works with standard chemotherapy in treating patients with newly diagnosed acute myeloid leukemia and a type of genetic mutation called MLL gene rearrangement. Pinometostat may stop the growth of cancer cel...

What is the current status of trial NCT03724084?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2019-04-10. Estimated completion is 2022-11-14.

What interventions are being tested in trial NCT03724084?

The interventions under investigation include: Cytarabine (DRUG), Daunorubicin (DRUG), Daunorubicin Hydrochloride (DRUG), Pinometostat (DRUG).

Who is sponsoring clinical trial NCT03724084?

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 NCT03724084's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT03724084, the US trial registry maintained by the National Library of Medicine. NCT03724084 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.