Actively Recruiting
Ziftomenib Maintenance Post Allo-HCT
Led by Massachusetts General Hospital · Updated on 2026-03-19
22
Participants Needed
2
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to test the safety, effects, and recommended dose of an investigational drug, ziftomenib, in addition to the standard treatment on blood cancer with Allogeneic Hematopoietic Cell Transplantation (allo-HCT). This study plans to learn more about ziftomenib, which targets and inhibits negative interactions within cancer cells related to AML, when given after allo-HCT, to determine if it improves outcomes following allo-HCT. The name of the study drug involved in this study is: • Ziftomenib
CONDITIONS
Official Title
Ziftomenib Maintenance Post Allo-HCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Pathologically confirmed diagnosis of acute myeloid leukemia (AML)
- Complete remission (CR) or complete remission with incomplete count recovery (CRi) at screening
- Presence of KMT2A rearrangement or NPM1 mutation confirmed by local testing
- Undergoing first allogeneic hematopoietic cell transplantation (allo-HCT) for AML
- Transplantation performed with myeloablative or reduced intensity conditioning
- Donor matched related, matched unrelated, haploidentical related, or umbilical cord blood donor
- Any non-investigational GVHD prophylaxis regimen allowed
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Normal organ function including liver enzymes, bilirubin, and creatinine clearance
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Negative pregnancy test for females of childbearing potential
- Agreement to use contraception during and 6 months after treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- History of other malignancies unless disease-free for at least 2 years and low risk of recurrence, or indolent cancer with no progression for 2 years, or prior cervical cancer in situ or certain skin cancers
- Active hepatitis B or C infection
- History of congestive heart failure (NYHA class 3 or 4) or heart dysfunction with LVEF less than 50%
- History of ventricular or life-threatening arrhythmias or long-QT syndrome
- Uncontrolled systemic infection
- Conditions limiting oral drug absorption such as dysphagia or gastroparesis
- Uncontrolled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg)
- QTc interval 480 ms or higher or other risk factors for arrhythmia
- Uncontrolled intercurrent illness limiting study compliance
- Pregnancy or lactation
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Ohio State University Wexner Medical Center- James Cancer Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
Z
Zachariah DeFilipp, 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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