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NCT05761171 · ClinicalTrials.gov registry record · Phase 2

A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia

A Phase 2 study of Refractory Acute Lymphoblastic Leukemia and Recurrent Acute Lymphoblastic Leukemia, sponsored by Children's Oncology Group.

Active
Registry status
Phase 2
Development phase
78
Enrollment target
20
Study locations

NCT05761171 is a Phase 2 study of Refractory Acute Lymphoblastic Leukemia and Recurrent Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 78 participants, above the 41-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (90% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT05761171, a Phase 2 study of Refractory Acute Lymphoblastic Leukemia and Recurrent Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by Children's Oncology Group.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
78 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial tests the safety and best dose of revumenib in combination with chemotherapy, and evaluates whether this treatment improves the outcome in infants and young children who have leukemia that has come back (relapsed) or does not respond to treatment (refractory) and is associated with a KMT2A (MLL) gene rearrangement (KMT2A-R). Leukemia is a cancer of the white blood cells, where too many underdeveloped (abnormal) white blood cells, called "blasts", are found in the bone marrow, which is the soft, spongy center of the bones that produces the three major blood cells: white blood cells to fight infection; red blood cells that carry oxygen; and platelets that help blood clot and stop bleeding. The blasts crowd out the normal blood cells in the bone marrow and spread to the blood. They can also spread to the brain, spinal cord, and/or other organs of the body. The leukemia cells of some children have a genetic change in which a gene (KMT2A) is broken and combined with other genes that typically do not interact with one another; this is called "rearranged". This genetic rearrangement alters how other genes are turned on or off in the cell, turning on genes that drive the development of leukemia. Patients with KMT2A rearrangement have higher risk for cancer coming back after treatment. Revumenib is an oral medicine that directly targets the changes that occur in a cell with a KMT2A rearrangement and has been shown to specifically kill these leukemia cells in preclinical laboratory settings and in animals. Drugs used in chemotherapy, such as vincristine, prednisone, asparaginase, fludarabine 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. This trial is being done to find out if the combination of revumenib and chemotherapy would be safe and/or effective in treating infants and young children with relapsed or refractory KMT2A-R leukemia

Conditions Studied

Refractory Acute Lymphoblastic Leukemia Recurrent Acute Lymphoblastic Leukemia Recurrent Mixed Phenotype Acute Leukemia Refractory Acute Leukemia of Ambiguous Lineage Recurrent Acute Leukemia of Ambiguous Lineage Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage Recurrent Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia Refractory Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage Refractory Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Aspiration
  • PROCEDURE Echocardiography Test
  • DRUG Cytarabine
  • DRUG Calaspargase Pegol

Study Locations (20)

Florida

  • Golisano Children's Hospital of Southwest Florida - Fort Myers
  • UF Health Cancer Institute - Gainesville - Gainesville
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital - Hollywood
  • Nicklaus Children's Hospital - Miami
  • AdventHealth Orlando - Orlando
  • Arnold Palmer Hospital for Children - Orlando
  • Nemours Children's Hospital - Orlando
  • Saint Joseph's Hospital/Children's Hospital-Tampa - Tampa

California

  • Kaiser Permanente Downey Medical Center - Downey
  • Loma Linda University Medical Center - Loma Linda
  • UCSF Benioff Children's Hospital Oakland - Oakland
  • Kaiser Permanente-Oakland - Oakland
  • UCSF Medical Center-Mission Bay - San Francisco

Alabama

  • Children's Hospital of Alabama - Birmingham

Arkansas

  • Arkansas Children's Hospital - Little Rock

Colorado

  • Children's Hospital Colorado - Aurora

Connecticut

  • Connecticut Children's Medical Center - Hartford

Delaware

  • Alfred I duPont Hospital for Children - Wilmington

District of Columbia

  • Children's National Medical Center - Washington D.C.

Trial Details

FieldValue
Enrollment Target 78 participants
Start Date 2024-01-08
Est. Completion 2027-12-31
Phase Phase 2

Sponsor

Children's Oncology Group

342 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05761171

The ClinicalTrials.gov registry entry for NCT05761171 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 41-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (90% higher). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Refractory Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05761171 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT05761171 about?

NCT05761171 is a clinical study titled "A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia". This phase II trial tests the safety and best dose of revumenib in combination with chemotherapy, and evaluates whether this treatment improves the outcome in infants and young children who have leukemia that has come back (relapsed) or does not respond to treatment (refractory) and is associated wi...

What is the current status of trial NCT05761171?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2024-01-08. Estimated completion is 2027-12-31.

What conditions does trial NCT05761171 study?

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

What interventions are being tested in trial NCT05761171?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Echocardiography Test (PROCEDURE), Cytarabine (DRUG), Calaspargase Pegol (DRUG).

Who is sponsoring clinical trial NCT05761171?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05761171 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. 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.