BlinatumomabPhase 1NCT07283640

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

A Phase 1 study testing Revumenib and Blinatumomab in people with Blinatumomab and Revumenib, run by M.D. Anderson Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Blinatumomab, Revumenib, Lymphoblastic Leukemia
What is being tested?: Revumenib and Blinatumomab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 18 Nov 2026to 31 Aug 2031
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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

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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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elias J Jabbour, MD contact

713-792-4764

ejabbour@mdanderson.org

United States1 site

MD Anderson Cancer
Houston, Texas, 77030
Elias J Jabbour, MD, 713-792-4764, ejabbour@mdanderson.org
Elias J Jabbour, MD

Other trials in United States

About this study

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.

Read the 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

Conditions: Blinatumomab, Revumenib, Lymphoblastic Leukemia, KMT2A-rearranged
Being tested: Revumenib, Blinatumomab
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RevumenibDrug
Given by po
BlinatumomabDrug
Given by IV

Study groups in NCT07283640
Study group	Role	What they receive
Cohort 1	Experimental	Treatment with SC Blinatumomab + Revumenib in R/R ALL Receives: Drug: Revumenib; Drug: Blinatumomab
Cohort 2	Experimental	Treatment with SC Blinatumomab + Revumenib in Newly Diagnosed ALL Receives: Drug: Revumenib; Drug: Blinatumomab

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 202631 Aug 2031

First posted16 Dec 2025
Study start18 Nov 2026 (estimated)
Primary completion31 Aug 2029 (estimated)
Study completion31 Aug 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for BlinatumomabStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07283640
Sponsor's protocol ID: 2025-0932
Other IDs: NCI-2025-09116
Status last verified: Aug 2026
First submitted: 4 Dec 2025
Last updated: 12 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

Elias J Jabbour, MD

713-792-4764

ejabbour@mdanderson.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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RecruitingPhase 2
Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy
Acute Lymphoblastic Leukemia, Immunotherapy
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Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus
Systemic Lupus Erythematosus (SLE), Children

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