Actively Recruiting
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-27
18
Participants Needed
7
Research Sites
188 weeks
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
The researchers are doing this study to see if the combination of gilteritinib with ivosidenib or enasidenib is a safe and effective treatment for people with relapsed/refractory AML with FLT3/IDH1 or FLT3/IDH2 gene mutations. The researchers will also look for the highest dose of the combination of gilteritinib with ivosidenib or enasidenib that causes few or mild side effects. When the highest safe dose is found, they will test that dose in new groups of participants.
CONDITIONS
Official 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 patient is 63;18 years of age at the time of signing the informed consent form (ICF)
- Patient is willing and able to adhere to the study visit schedule and other protocol requirements
- Confirmed diagnosis of relapsed AML as per WHO (2016) guidelines or refractory AML as defined by persistent disease after treatment
- Relapsed or refractory AML with co-occurring IDH2/FLT3, IDH1/FLT3 (ITD or TKD), or other FLT3 mutation sensitive to gilteritinib
- Documentation of FLT3 and IDH1 or IDH2 mutation in bone marrow or blood within 30 days by local CLIA approved test
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- Adequate renal function with creatinine clearance 63;30mL/min or serum creatinine less than 2.0
- Adequate hepatic function with AST and ALT 64 3x ULN and serum direct bilirubin 64 2.0 x ULN (up to 5.0 x ULN if leukemic organ involvement)
- Previous autologous or allogeneic stem cell transplant for AML allowed
- Female patients of childbearing potential must have negative pregnancy test and agree to use two forms of birth control during and 6 months after treatment
- Male participants with female partners of childbearing potential must agree to use contraception during treatment and for 6 months after last dose
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 infection
- Any condition that increases risk associated with study participation as judged by investigator
- Immediate life-threatening severe leukemia complications such as uncontrolled bleeding or severe pneumonia
- Significant active cardiac disease within 6 months before study including NYHA class III/IV heart failure, acute coronary syndrome, or ischemic stroke
- Left ventricular ejection fraction (LVEF) less than 40% within 28 days prior to study
- Conditions limiting oral drug absorption such as dysphagia or gastroparesis
- History of progressive multifocal leukoencephalopathy
- QTc interval 63 450 ms or other risks for QT prolongation or arrhythmia unless approved by investigator
- Active graft-versus-host disease (except isolated skin GVH controlled with topical steroids)
- Female patients who are pregnant or lactating
AI-Screening
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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
CONTACT
A
Aaron Goldberg, MD,PhD
CONTACT
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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