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RecruitingPhase 1NCT06575296

Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant

A Phase I Study of SNDX 5613 (Revumenib) as Post-Transplant Maintenance After Allogeneic Hematopoietic Cell Transplant in Patients With KMT2A-Rearranged or NPM1-Mutated Acute Leukemia

Sponsor

City of Hope Medical Center

Enrollment

27 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAcute LeukemiaAcute Leukemia of Ambiguous LineageChildhood Acute LeukemiaChildhood Acute Lymphoblastic LeukemiaChildhood Acute Leukemia of Ambiguous LineageChildhood Acute Myeloid Leukemia

Summary

This phase I trial tests the safety, side effects, best dose and effectiveness of revumenib in treating patients with acute leukemia after allogeneic stem cell transplant. Revumenib is in a class of medications called menin inhibitors. Revumenib targets and binds to the protein menin, thereby preventing the interaction between menin and the mixed lineage leukemia protein. Disrupting this interaction prevents the activation of specific genes that fuel the development of leukemia cells and inhibits the survival, growth, and production of certain kinds of leukemia cells. Giving revumenib may be safe, tolerable, and/or effective in treating patients with acute leukemia after allogeneic stem cell transplant.

Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called revumenib for people with acute leukemia (a fast-growing blood cancer) who are undergoing or have already received a stem cell transplant from a donor. Revumenib targets a protein called menin that some leukemia cells depend on to grow. **You may be eligible if...** - You are 2 years old or older - You have been diagnosed with acute leukemia - You are scheduled to receive or have already received an allogeneic (donor) stem cell transplant - Your performance status and organ function meet the study requirements **You may NOT be eligible if...** - You have serious infections, organ problems, or other cancers that would make treatment unsafe - You are pregnant - You are not a candidate for or have not received a donor stem cell transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREEchocardiography

Undergo ECHO

OTHERElectronic Health Record Review

Ancillary studies

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

DRUGRevumenib

Given PO

Locations(1)

City of Hope Medical Center

Duarte, California, United States

View Full Details on ClinicalTrials.gov

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NCT06575296

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