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

NCT07283640 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2025-0932NCI-2025-09116
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blinatumomab; Revumenib; Lymphoblastic Leukemia; KMT2A-rearranged

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion; an average of 1 year

Study Arms (2)

Cohort 1

EXPERIMENTAL

Treatment with SC Blinatumomab + Revumenib in R/R ALL

Drug: Revumenib; Drug: Blinatumomab

Cohort 2

EXPERIMENTAL

Treatment with SC Blinatumomab + Revumenib in Newly Diagnosed ALL

Drug: Revumenib; Drug: Blinatumomab

Interventions

Revumenib DRUG

Given by po

Cohort 1; Cohort 2

Blinatumomab DRUG

Given by IV

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Amgen: collaborator
• Syndax Pharmaceuticals: collaborator

Study Sites (1)

MD Anderson Cancer

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

revumenib; blinatumomab

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Elias J Jabbour, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elias J Jabbour, MD

CONTACT

713-792-4764; ejabbour@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 16, 2025
• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2031
• Last Updated: May 5, 2026

Record last verified: 2025-12

Locations

US (1)