Study of Blinatumomab and Revumenib for KMT2A-rearranged ALL

This study is testing two drugs, blinatumomab and revumenib, in people with acute lymphoblastic leukemia (ALL) that has a specific genetic change called a KMT2A rearrangement. This includes people who are newly diagnosed, or whose ALL has come back or isn't responding to treatment. The main goal is to see how safe the combination of blinatumomab and revumenib is and what side effects it might cause. Researchers will also look at how well the treatment works to reduce the leukemia. About 20 participants are planned for this study. The current status of this study is unclear, meaning it might be open for enrollment or not yet recruiting.

Study design
This is an interventional study planning to enroll 20 participants. It is designed to evaluate the safety and effectiveness of two drugs in combination.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, which is an average of 1 year.

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NCT07283640

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

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~20 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:RevumenibBlinatumomab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs).
Measured over Through study completion; an average of 1 year
Blinatumomab
Revumenib
Lymphoblastic Leukemia
KMT2A-rearranged
1 sites across 1 states
Texas1
  • Elias J Jabbour, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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Eligibility criteria

Exclusion

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)
  • Safety and adverse events (AEs).Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0