Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Primary Outcome

Regimen A Cycle 1 will be used for determination of recommended phase 2 dose (RP2D)-lymphoid (L) directed chemotherapy block. A patient will be considered as being evaluable for DLT if: (1) the patient receives at least 44 doses of the first planned 28 days (56 doses) of revumenib for cycle 1 (for patients with delayed revumenib shipment, will count 28 days from the start of revumenib); or (2) the patient experiences a DLT after the start of revumenib in that cycle.

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
Children's Oncology Group

342 total trials

What the registry record for NCT05761171 still lists

NCT05761171 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 41-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (90% higher).

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 names 20 study sites across 9 states, led by 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.

Learn More About Clinical Trials

Similar trials for Refractory Acute Lymphoblastic 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 NCT05761171's enrollment target sits among peer trials

78 3rd of 21 higher than 19 of 21 other Refractory Acute Lymphoblastic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Refractory Acute Lymphoblastic 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02397668 · 78 participants · NA

    CorMatrix Cor TRICUSPID ECM Valve Replacement Study

  • NCT03321656 · 78 participants · Phase 2

    Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile

  • NCT03687814 · 78 participants · NA

    Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation

  • NCT04018872 · 78 participants · Phase 2

    Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT05761171, the US trial registry maintained by the National Library of Medicine. NCT05761171 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.