Actively Recruiting
A Phase 1b Study of Gilteritinib Combined With Ivosidenib or Enasidenib for Relapsed or Refractory Acute Myeloid Leukemia with FLT3/IDH1 or FLT3/IDH2 Mutations
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-27
18
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
A
Astellas Pharma US, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of gilteritinib with ivosidenib or enasidenib as a potential treatment for adults with relapsed or refractory acute myeloid leukemia (AML) who have specific gene mutations in FLT3 and IDH1 or IDH2. This Phase 1b study aims to find the highest dose of these drug combinations that causes only mild or manageable side effects and to assess their safety and effectiveness. Participants are divided into two groups: one group receives gilteritinib combined with ivosidenib, and the other receives gilteritinib combined with enasidenib. Both combinations are taken daily in continuous 28-day cycles at assigned dose levels, with different doses tested to find the maximum tolerated dose. The study is non-randomized and open-label, meaning participants and researchers know which treatments are given. During the study, participants will be monitored for side effects and toxicities for up to one year while researchers determine the safest dose. Clinical responses to the treatment will also be evaluated during this period. Participants will undergo regular assessments including blood tests and mutation analysis to track their health and treatment effects. The study is sponsored by Memorial Sloan Kettering Cancer Center and participation lasts as long as needed to evaluate safety and response.
CONDITIONS
Brief Title
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older at the time of consent
- Willing and able to follow study visit schedules and protocol requirements
- Confirmed diagnosis of relapsed AML or refractory AML as defined by specific treatment responses
- Relapsed or refractory AML with FLT3 and IDH1 or IDH2 mutations confirmed by recent genetic testing
- ECOG performance status between 0 and 3
- Adequate kidney function (creatinine clearance ≥30 mL/min or serum creatinine <2.0)
- Adequate liver function with AST and ALT ≤3 times upper limit of normal and bilirubin ≤2.0 times upper limit, except in certain leukemic organ involvement
- Prior autologous or allogeneic stem cell transplant allowed
- Female patients of childbearing potential must have a negative pregnancy test and agree to use two effective birth control methods during and 6 months after treatment
- Male participants with partners of childbearing potential must agree to use contraception during treatment and for 6 months after
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL)
- Use of other investigational anti-cancer agents
- Active uncontrolled systemic fungal, bacterial, or viral infections
- Any condition that increases study participation risk as judged by investigator
- Immediate life-threatening complications of leukemia such as uncontrolled bleeding or severe disseminated intravascular coagulation
- Significant active cardiac disease within 6 months prior to study, including severe heart failure, recent heart attack, or ischemic stroke
- Left ventricular ejection fraction below 40% by recent heart imaging
- Conditions limiting oral drug absorption such as dysphagia or gastroparesis
- History of progressive multifocal leukoencephalopathy
- QTc interval ≥450 ms or other factors increasing risk of abnormal heart rhythms unless approved by the principal investigator
- Active graft-versus-host disease except controlled skin GVHD with topical steroids
- Female patients who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants take a combination of gilteritinib with ivosidenib or enasidenib daily in continuous 28-day cycles at assigned dose levels.
Visits occur regularly during each treatment cycle as scheduled by the study team
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
E
Eytan Stein, MD
A
Aaron Goldberg, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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