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IDH2 Inhibitor Combination
Gilteritinib + Ivosidenib/Enasidenib for Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Eytan Stein, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patient is ≥18 years of age at the time of signing the informed consent form (ICF)
Patient has documentation of FLT3 and IDH1 or IDH2 mutation in bone marrow or blood at time of relapsed/refractory status confirmed by next-generation sequencing (NGS) and/or polymerase chain reaction (PCR) or fragment length analysis within the previous 30 days by a local CLIA approved test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test if a combination of two drugs is a safe and effective treatment for people with relapsed/refractory AML with certain gene mutations. Researchers will look for the safest dose.
Who is the study for?
Adults over 18 with relapsed or refractory Acute Myeloid Leukemia (AML) and specific gene mutations (FLT3/IDH1 or FLT3/IDH2). They must be able to follow the study plan, have adequate organ function, and not be pregnant. Men and women must agree to use birth control. Exclusions include uncontrolled infections, severe leukemia complications, heart issues, absorption problems, certain neurological diseases, and those on other cancer trials.Check my eligibility
What is being tested?
The trial is testing if combining gilteritinib with ivosidenib or enasidenib is safe and effective for AML patients with certain genetic mutations. It aims to find the highest dose that causes few side effects before using this dose in new participant groups.See study design
What are the potential side effects?
Potential side effects may include typical reactions from cancer treatments such as nausea, fatigue, liver issues but will focus on identifying mild side effects at the safest maximum doses of the drug combination.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years or older and can sign the consent form.
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My tests show FLT3 and IDH mutations in my recent relapse.
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My liver tests are within the required limits.
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My AML is not responding to treatment.
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My AML has come back or hasn't responded to treatment and has specific genetic changes.
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My kidney function is good, with a creatinine clearance rate of at least 30 mL/min or my serum creatinine is less than 2.0.
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I have had a stem cell transplant for my AML.
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I can care for myself but may not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events /toxicities
Determine the maximum tolerated dose (MTD)
Secondary outcome measures
Clinical response
Trial Design
2Treatment groups
Experimental Treatment
Group I: gilteritinib + ivosidenib (Cohort 1)Experimental Treatment2 Interventions
Each patient will take the combination of gilteritinib/ ivosidenib (Cohort 1) , daily, in continuous 28-day cycles at the dose level that they are assigned.
Group II: gilteritinib + enasidenib (Cohort 2)Experimental Treatment2 Interventions
Each patient will take the combination of gilteritinib/enasidenib (Cohort 2) daily, in continuous 28-day cycles at the dose level that they are assigned.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gilteritinib
2014
Completed Phase 2
~560
Enasidenib
2020
Completed Phase 2
~560
Ivosidenib
2019
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Astellas Pharma US, Inc.Industry Sponsor
88 Previous Clinical Trials
12,797 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,586 Total Patients Enrolled
Eytan Stein, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
27 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of a brain infection called PML.My tests show FLT3 and IDH mutations in my recent relapse.I have an ongoing serious infection that isn't under control.I have graft-versus-host disease but it's only affecting my skin and is controlled with creams.I have been diagnosed with acute promyelocytic leukemia.I haven't had serious heart problems like heart failure or a stroke in the last 6 months.My heart's electrical cycle is longer than normal or I have a high risk of irregular heartbeats.I am currently pregnant or breastfeeding.My kidney function is good, with a creatinine clearance rate of at least 30 mL/min or my serum creatinine is less than 2.0.I have had a stem cell transplant for my AML.My AML is not responding to treatment.My heart's pumping ability is less than 40% as shown by a recent heart scan.I agree to use contraception during the study and for 6 months after.I can care for myself but may not be able to do heavy physical work.I am willing and able to follow the study's schedule and requirements.I am 18 years or older and can sign the consent form.I am not pregnant, can use two birth control methods during the study, and will continue for 6 months after.I have AML that has come back or still shows minimal signs after treatment.I have a condition that affects my ability to swallow or absorb pills.I am experiencing severe, life-threatening complications from leukemia.My AML has come back or hasn't responded to treatment and has specific genetic changes.My liver tests are within the required limits.
Research Study Groups:
This trial has the following groups:- Group 1: gilteritinib + enasidenib (Cohort 2)
- Group 2: gilteritinib + ivosidenib (Cohort 1)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies available to volunteers for this experimental research trial?
"The information posted on clinicaltrials.gov suggests that this medical trial is no longer accepting participants, as the experiment was first created in March 1st of 2023 and last edited three days later. Despite its closure, there are still 1539 other trials actively searching for patients."
Answered by AI
How precarious are the potential risks associated with gilteritinib + ivosidenib (Cohort 1) to human health?
"Considering the experimental nature of gilteritinib + ivosidenib (Cohort 1), Power's team rated its safety as a conservative score of 1, due to limited data for both efficacy and safety."
Answered by AI
How many venues is this scientific inquiry being conducted in?
"There are seven medical sites conducting this study, spanned across Middletown, Montvale and Commack as well other urban areas. It is recommended to choose the closest location for trial participation to reduce time spent on travelling."
Answered by AI
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