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Gilteritinib + Ivosidenib/Enasidenib for Acute Myeloid Leukemia
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.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: gilteritinib + enasidenib (Cohort 2)
- Group 2: gilteritinib + ivosidenib (Cohort 1)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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