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NCT04065399 · ClinicalTrials.gov registry record · Phase 1

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

A Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Syndax Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
447
Enrollment target
20
Study locations

NCT04065399 is a Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Syndax Pharmaceuticals. The registered enrollment target is 447 participants, above the 114-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (292% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT04065399, a Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Syndax Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
447 participants
Enrollment target
20
Study locations

Study Summary

Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia. In Phase 2, participants will be enrolled in 4 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib.

Conditions Studied

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Mixed Phenotype Acute Leukemia Acute Leukemia of Ambiguous Lineage Mixed Lineage Acute Leukemia

Interventions

  • DRUG revumenib
  • DRUG cobicistat

Study Locations (20)

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • University Of California Care Medical Group - Norris Comprehensive Cancer Center And Hospital - Los Angeles
  • Stanford Cancer Institute - Palo Alto

Florida

  • Florida Cancer Specialists and Research Institute - Sarasota
  • Moffitt Cancer Center - Tampa

Georgia

  • Emory Winship Cancer Institute - Atlanta
  • Children's Healthcare of Atlanta - Atlanta

New York

  • Memorial Sloan Kettering Cancer Center - New York
  • Montefiore Medical Center - New York

Ohio

  • University of Cincinnati - Cincinnati
  • Ohio State University - Columbus

Colorado

  • University of Colorado - Aurora

Illinois

  • The University of Chicago Medical Center - Chicago

Iowa

  • University of Iowa Hospital - Iowa City

Trial Details

FieldValue
Enrollment Target 447 participants
Start Date 2019-11-05
Est. Completion 2027-12-15
Phase Phase 1

Sponsor

Syndax Pharmaceuticals

25 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04065399

The ClinicalTrials.gov registry entry for NCT04065399 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 447 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 114-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (292% higher). The listed sponsor is Syndax Pharmaceuticals, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which revumenib is the first listed.

NCT04065399 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT04065399 about?

NCT04065399 is a clinical study titled "A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation". Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia. In Phase 2, participants will be enrolled in 4 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, ...

What is the current status of trial NCT04065399?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 447 participants. The study started on 2019-11-05. Estimated completion is 2027-12-15.

What conditions does trial NCT04065399 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia, Acute Leukemia of Ambiguous Lineage, Mixed Lineage Acute Leukemia.

What interventions are being tested in trial NCT04065399?

The interventions under investigation include: revumenib (DRUG), cobicistat (DRUG).

Who is sponsoring clinical trial NCT04065399?

This trial is sponsored by Syndax Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04065399 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.