Actively Recruiting
Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant
Led by City of Hope Medical Center · Updated on 2026-03-05
27
Participants Needed
1
Research Sites
177 weeks
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
This phase I trial tests the safety, side effects, best dose and effectiveness of revumenib in treating patients with acute leukemia after allogeneic stem cell transplant. Revumenib is in a class of medications called menin inhibitors. Revumenib targets and binds to the protein menin, thereby preventing the interaction between menin and the mixed lineage leukemia protein. Disrupting this interaction prevents the activation of specific genes that fuel the development of leukemia cells and inhibits the survival, growth, and production of certain kinds of leukemia cells. Giving revumenib may be safe, tolerable, and/or effective in treating patients with acute leukemia after allogeneic stem cell transplant.
CONDITIONS
Official 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 who have undergone or are scheduled to undergo allogeneic hematopoietic cell transplantation (alloHCT)
- Documented informed consent from the participant or legal representative
- Agreement to allow use of archival tissue from diagnostic tumor biopsies or investigator-approved exception
- Willingness and ability to adhere to study visits and protocol requirements
- Diagnosis of acute leukemia (AML, ALL, or ambiguous lineage) with KMT2A rearrangement or NPM1 mutation
- For NPM1 mutated AML, additional criteria such as FLT3-ITD co-mutation, pre-transplant minimal residual disease, multiple induction regimens, or second/later remission
- Any donor type or graft source accepted
- Conditioning and graft-versus-host disease (GVHD) prophylaxis per investigator's choice
- Patients receiving menin inhibitors before transplant are eligible
- Negative pregnancy test for females of childbearing potential post-transplant
- Use of effective contraception for patients of childbearing potential during and 120 days after treatment
- Performance status ECOG ≤ 2, Karnofsky ≥ 70, or Lansky ≥ 70 if under 18
- Eligible for alloHCT by center guidelines
- In complete remission by day +30 post-transplant with no active or uncontrolled infection
- No active grade 2-4 acute GVHD and adequate blood counts without transfusion support
- Fully engrafted with ANC ≥ 500 for 3 days without growth factor support prior to treatment
- Between day +50 and +150 post-transplant with no morphologic relapse
- Liver, kidney, cardiac function within specified limits
- QTc interval within normal limits
- Ejection fraction ≥ 50% by echocardiogram or MUGA scan
- Creatinine clearance ≥ 60 mL/min
You will not qualify if you...
- Prior diagnosis of acute promyelocytic leukemia
- Inability to take strong CYP3A4 inhibitors like voriconazole or posaconazole
- Use of medications that prolong QT/QTc interval except low-risk supportive drugs
- Conditions or allergies that may interfere with study participation or safety
- Inability to comply with study procedures
- Detectable HIV viral load within past 6 months
- Active uncontrolled hepatitis B or C infection
- Other active malignancies that may interfere with study assessments
- Active grade II-IV acute GVHD or moderate/severe chronic GVHD requiring systemic steroids
- Active uncontrolled systemic infections
- Pregnant or breastfeeding females
- Malabsorption syndrome or conditions preventing oral drug administration
- Chronic respiratory disease requiring continuous oxygen
- Significant medical conditions affecting participation (renal, neurologic, psychiatric, hepatic, cardiovascular, etc.)
- Recent serious cardiac events within 6 months (heart attack, unstable angina, heart failure, arrhythmia, stroke, or transient ischemic attack)
- Gastrointestinal diseases affecting drug absorption or severe liver disease
- Signs or symptoms of GVHD greater than grade 0 within 4 weeks prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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