Revumenib + Blinatumomab for Acute Lymphoblastic Leukemia

Overseen By Elias J Jabbour, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Active infection, Secondary malignancy, Psychiatric illness, Untreated CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effects of combining two treatments, revumenib and blinatumomab, for individuals with Acute Lymphoblastic Leukemia (ALL). The focus is on those with a rearrangement in the KMT2A gene, which can make the cancer more difficult to treat. The study includes two groups: one for newly diagnosed individuals unfit for intense chemotherapy and another for those whose cancer has returned or not responded to treatment. Ideal candidates for this trial have the specific KMT2A gene change and persistent cancer after other treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment combination.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of revumenib and blinatumomab is under study for safety and effectiveness in treating acute lymphoblastic leukemia (ALL). Studies have found that blinatumomab is generally well-tolerated, with 39% of patients experiencing complete remission, meaning their cancer symptoms disappeared. This suggests it can work well without causing severe side effects for many people.

Separate research on revumenib has shown promising results. With an average follow-up of 9.3 months, 68% of patients were still alive after six months of treatment, suggesting it might have lasting effects while being relatively safe.

Since this trial is in an early stage, information on the safety of using both drugs together might be limited. However, because blinatumomab has been safe in past studies and revumenib has shown encouraging early results, the combination might be expected to be tolerable. Always consult the trial team for the most detailed safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Revumenib and Blinatumomab for treating acute lymphoblastic leukemia (ALL) because these treatments target cancer cells in novel ways. Unlike traditional chemotherapy, which kills both healthy and cancerous cells, Blinatumomab is a type of immunotherapy that helps the immune system specifically attack leukemia cells. Revumenib works by blocking specific proteins that help leukemia cells survive, offering a new line of attack. Together, these drugs aim to improve treatment outcomes by precisely targeting cancer cells while sparing healthy ones, potentially leading to fewer side effects and more effective results.

What evidence suggests that this trial's treatments could be effective for acute lymphoblastic leukemia?

Studies have shown that blinatumomab can significantly improve survival rates for certain types of acute lymphoblastic leukemia (ALL). Specifically, patients treated with blinatumomab had a 5-year survival rate of 78.4%, much higher than those who only received chemotherapy. Research on revumenib suggests promise for patients with KMT2A-rearranged ALL, a type of leukemia that often requires targeted treatments. Revumenib is under study for its potential to improve outcomes. Early results from studies with infants showed a 3-year survival rate of 66% for those with this specific leukemia type. In this trial, participants will receive a combination of blinatumomab and revumenib, potentially treating ALL more effectively by combining their strengths. ^{1 3 6 7 8}

Who Is on the Research Team?

Elias J Jabbour, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with a specific type of leukemia called KMT2A-rearranged Acute Lymphoblastic Leukemia (ALL), either newly diagnosed or relapsed/refractory. The detailed eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.

Inclusion Criteria

Unfit for intensive chemotherapy defined as: ECOG >2, Severe cardiac disorder, Severe pulmonary disorder, Creatinine clearance <45 ml/min, Hepatic disorder with total bilirubin 1.5 x upper limit of normal, Performance status <2 per ECOG scale, Adequate liver function, Adequate pancreatic function, Negative pregnancy test for females of childbearing potential, Adequate contraception for women of child-bearing potential and men, Adequate cardiac function, White blood cell count below 25,000/uL, Estimated glomerular filtration rate >60 ml/min/1.73m2, Time elapsed since stem cell transplant or donor lymphocyte infusion, Time elapsed since immunotherapy, Weight of at least 40 kg, Ability to understand and sign a written informed consent document

I am over 18 and have measurable leukemia cells in my body.

I am over 18 and my leukemia has returned or is not responding to treatment.

Exclusion Criteria

I do not have a long QT syndrome, severe liver disease, or a heart condition with QTcF >450 msec.

I have an active hepatitis B or C infection.

Detectable HIV viral load within the previous 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous Blinatumomab in combination with Revumenib

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blinatumomab
• Revumenib

Trial Overview

The trial is testing the safety and effects of combining two drugs: Revumenib and Blinatumomab. It's aimed at patients with Ph-negative ALL who have a genetic change known as KMT2A rearrangement.

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 2 Interventions

Treatment with SC Blinatumomab + Revumenib in Newly Diagnosed ALL

Group II: Cohort 1 Experimental Treatment 2 Interventions

Treatment with SC Blinatumomab + Revumenib in R/R ALL

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Syndax Pharmaceuticals

Industry Sponsor

Trials

49

Recruited

2,700+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05761171

NCT05761171 | A Study of Revumenib in Combination ...

This phase II trial tests the safety and best dose of revumenib in combination with chemotherapy, and evaluates whether this treatment improves the outcome ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12712861

Adult Acute Lymphoblastic Leukemia: 2025 Update on ...

The combination of a TKI with a backbone of multiagent chemotherapy, or more recently blinatumomab, is the mainstay of therapy, resulting in 5-year survival ...

3.

jmcp.org

jmcp.org/doi/pdf/10.18553/jmcp.2025.25027?download=true

Budget impact analysis of revumenib for the treatment of ...

Results of salvage therapy with mini-hyper-CVD and inotuzumab ozogamicin with or without blinatumomab in pre-B acute lymphoblastic leukemia. J Hematol Oncol ...

4.

oncologynewscentral.com

oncologynewscentral.com/article/fda-approves-blinatumomab-for-consolidation-for-some-b-cell-acute-lymphoblastic-leukemia

FDA Approves Blinatumomab for Consolidation in Some B- ...

Specifically, 5-year OS was 78.4% (95% CI, 64.2%–87.4%) in the blinatumomab group and 41.4% (95% CI, 26.3%–55.9%) in the chemotherapy group, for ...

5.

haematologica.org

haematologica.org/article/view/12017

rearranged acute lymphoblastic leukemia in infants: current ...

As mentioned above, this trial showed a remarkably good outcome with a 3-year event-free survival of 66% for infants with KMT2A-rearranged ALL.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12206480/

Moving the Needle in KMT2A Rearranged Pediatric B-Cell ...

Blinatumomab led to CR rates of 39% in patients treated at the phase-2 dosing along with reasonable safety. Notably in this study, blinatumomab ...

7.

ichgcp.net

ichgcp.net/clinical-trials-registry/NCT07283640

Blinatumomab and Revumenib in Lymphoblastic Leukemia ...

To learn about the safety and effects of revumenib in combination with blinatumomab in patients with newly diagnosed or relapsed/refractory ...

8.

ir.syndax.com

ir.syndax.com/news-releases/news-release-details/syndax-presents-positive-revuforjr-revumenib-data-acute

Syndax Presents Positive Revuforj® (revumenib) Data in ...

With a median follow-up of 9.3 months (N=33), the 6-month overall survival (OS) was 68% (95% CI: 47%, 80%); median OS was not reached. The median duration of CR ...