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A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia

NCT07283640•M.D. Anderson Cancer Center

Summary

To learn about the safety and effects of revumenib in combination with blinatumomab in patients with newly diagnosed or relapsed/refractory Ph-negative ALL with a KMT2A rearrangement.

Detailed Description

Primary Objectives * To determine the safety of recommended dose by 20 participants including 10 relapsed/refractory participants (cohort 1) and 10 newly diagnosed participants (cohort 2). * To evaluate the overall response rate (combination of complete remission \[CR\] + complete remission with incomplete count recovery \[CRi) + complete remission with incomplete hematologic recovery \[CRh\]) of the combination of SC blinatumomab and revumenib in cohort 1 and cohort 2 (participants with MRD-only disease will not be included towards the overall response rate) * To evaluate event-free survival (EFS, defined as the time from treatment initiation to relapse, death, or documented treatment failure) in cohort 2 Secondary Objectives * To evaluate overall survival (OS, defined as the time from treatment initiation to death from any cause) * To summarize the safety of the combination of revumenib and SC blinatumomab at all revumenib doses tested * To evaluate measurable residual disease (MRD) negativity by flow cytometry (sensitivity of 10-4) and ClonoSeq NGS (sensitivity of 10-6) * To characterize the frequency of lineage switch after treatment with the combination of revumenib and SC blinatumomab

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eligibility Criteria
•The following groups of participants will be eligible:
•Participants \> 18 years of age with relapsed and/or refractory (defined as \>5% blasts in the peripheral blood or bone marrow) KMT2A-r B-cell ALL or
•Participants \>18 years of age with persistent measurable residual disease by flow cytometry or next generation sequencing KMT2A-r B-cell ALL or
•Newly diagnosed participants with KMT2A-r B-cell ALL \> 60 years old or unfit for intensive chemotherapy
•Unfit for intensive chemotherapy defined as:
•ECOG \>2
•Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction \<50%, or chronic stable angina)
•Severe pulmonary disorder (e.g., DLCO \<65% or FEV1 \<65%)
•Creatinine clearance \<45 ml/min
+21 more criteria

Exclusion Criteria

•Active serious infection not controlled by oral or IV antibiotics
•Active secondary malignancy other than skin cancer (basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
•Participants with psychiatric illness that would limit compliance with study requirements
•Untreated CNS disease. Participants with controlled CNS disease may be included (as defined by being asymptomatic and having CNS cleared of leukemic involvement)
•Detectable HIV viral load within the previous 6 months. Participants with a known history of HIV must have viral load testing prior to study enrollment.
•Any of the following within 6 months prior to study entry: myocardial infarction, congestive heart failure New York Heart Association Classification Class \> II, life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack
•QTc using Friderica's correction (QTcF) \>450 msec
•Personal of family history of long QT syndrome
•Cirrhosis with a Child Pugh score of B or C
•Participants with active hepatitis B (defined as Hepatitis B surface antigen with detectable Hepatitis B virus DNA by PCR) or hepatitis C infection (defined as presence of detectable Hepatitis C virus RNA by PCR)

Locations (1)

MD Anderson Cancer

Houston, Texas, United States

Key Dates

Start Date

May 18, 2026

Primary Completion Date

August 31, 2029

Completion Date

August 31, 2031

Last Updated

December 22, 2025

Enrollment

ESTIMATED participants

Conditions

BlinatumomabRevumenibLymphoblastic LeukemiaKMT2A-rearranged

Interventions

Revumenib

DRUG

Blinatumomab

DRUG

Contacts

Elias J Jabbour, MD

CONTACT

713-792-4764 ejabbour@mdanderson.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia

Inclusion Criteria

Exclusion Criteria

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