Actively Recruiting
A Phase I Study of Revumenib as Post-Transplant Maintenance in Patients With KMT2A-Rearranged or NPM1-Mutated Acute Leukemia
Led by City of Hope Medical Center · Updated on 2026-03-05
27
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating revumenib, a menin inhibitor, in a phase I clinical trial for patients with acute leukemia, specifically those with KMT2A rearranged or NPM1 mutated leukemia, after receiving an allogeneic hematopoietic cell transplant (alloHCT). The study aims to assess the safety, side effects, best dose, and possible effectiveness of revumenib as a maintenance therapy to prevent leukemia relapse and support survival. This trial also explores effects on graft versus host disease (GVHD), immune recovery, and quality of life. Participants start revumenib treatment between 50 and 150 days after their transplant. The medication is taken orally once daily or every 12 hours on days 1 to 28 of each 28-day cycle. Treatment may continue for up to two years if the disease does not progress and side effects remain acceptable. Bone marrow biopsies, echocardiograms, and blood sample collections are part of the study procedures to monitor health and treatment effects throughout the trial. During the study, participants will have regular assessments including bone marrow aspiration, blood tests, and quality-of-life questionnaires. Researchers will track adverse events, overall survival, disease relapse, GVHD incidents, and molecular disease markers for up to two years. After completing treatment, participants will be followed up at 30 days and then every three months for up to two years to monitor long-term outcomes and safety.
CONDITIONS
Brief Title
Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 2 years or older
- Diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, or acute leukemia with ambiguous lineage per WHO criteria
- Confirmed KMT2A rearranged acute leukemia or NPM1 mutated AML with specific disease characteristics
- Scheduled for or have undergone allogeneic hematopoietic cell transplant within the last 4 months or next 4 weeks
- Willing and able to follow study visit schedule and protocol requirements
- Negative pregnancy test and use of effective contraception for females of childbearing potential
- Agreement to allow use of archival tissue or provide approval for exceptions
- Eligible for transplant by institutional guidelines
- No evidence of relapse and in complete remission at day +30 post-transplant
- Adequate organ function and performance status (ECOG ≤2 or KPS ≥70)
You will not qualify if you...
- Prior diagnosis of acute promyelocytic leukemia
- Unable to take a strong CYP3A4 inhibitor antifungal medication
- Concurrent use of medications that prolong QT/QTc interval except certain supportive drugs
- Active uncontrolled infections or uncontrolled acute or chronic graft versus host disease
- Pregnant or lactating females
- Malabsorption syndrome or conditions preventing oral drug administration
- Significant uncontrolled cardiac, respiratory, renal, neurologic, psychiatric, metabolic, immunologic, hepatic, or other medical conditions
- Recent serious cardiac events within 6 months including myocardial infarction or heart failure
- Gastrointestinal diseases affecting drug absorption, or cirrhosis with Child-Pugh B or C
- Active uncontrolled hepatitis B or C, or detectable HIV viral load in the past 6 months
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 2 years in the absence of disease progression or unacceptable toxicity
Participants receive revumenib orally once daily or every 12 hours on days 1-28 of each 28-day cycle as maintenance therapy after allogeneic stem cell transplant.
Monthly visits for up to 2 years
Duration - Up to 2 years post-treatment start
Participants are monitored after completing treatment to assess long-term outcomes and safety.
Visits at 30 days post-treatment and then every 3 months for up to 2 years
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
Research Team
B
Brian Ball, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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