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Gilteritinib vs Midostaurin for Acute Myeloid Leukemia
Study Summary
This trial will compare the effectiveness of two drugs, gilteritinib and midostaurin, in patients with FLT3 acute myeloid leukemia who are also receiving standard chemotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 1 & 2 trial • 265 Patients • NCT02014558Trial Design
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Who is running the clinical trial?
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- I do not have another cancer that could affect this treatment's results.I can care for myself but may not be able to do heavy physical work.I haven't taken any hypomethylating agents in the last 21 days.My organ functions are within the required range for the trial.I do not have active leukemia in my brain or spinal cord.My AML does not involve specific genetic changes (t(8;21), inv(16), t(16;16)).My heart is healthy and I don't have severe heart issues or uncontrolled chest pain.I have received treatment for MDS or MPN before.I am willing to give consent for my bone marrow or blood samples to be tested.My AML is FLT3 mutated and I haven't received treatment for it.I do not have a history of Long QT Syndrome.I am not taking medication that strongly affects certain liver enzymes and proteins.You are allergic to any of the medications being used in the study or their ingredients.I started the standard 7+3 chemotherapy as the protocol describes while waiting for test results.I am receiving or have received preventive brain chemotherapy.I don't have GI issues that affect my ability to take pills.I am between 18 and 70 years old.I can start standard chemotherapy before joining the trial while waiting for test results.I have received hydroxyurea or specific treatments before APL was ruled out.My leukemia is not classified as M3.I haven't had major surgery or radiation therapy in the last 4 weeks.
- Group 1: Arm A
- Group 2: Arm B
- 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
Is enrollment still open for this experiment?
"This study has concluded its recruitment efforts as of November 17th 2022. If you are searching for other trials, there exist 1532 active studies with acute leukemia and myelocytic cancer and 273 clinical trials utilizing gilteritinib actively recruiting patients."
How many institutes are administering this research endeavor?
"This medical trial is enrolling at a total of 44 sites, with some in Los Angeles, Orange and Boston. To reduce the burden of travelling for participants, it may be prudent to select the closest clinic location when considering enrollment."
Are there any potential safety hazards associated with Gilteritinib treatment?
"With a score of 2, Gilteritinib is thought to be moderately safe as there are some studies that support its safety but none verifying its efficacy."
May elderly individuals aged 70 and above take part in this scientific experiment?
"The age parameter for this medical examination is 18 to 70 years old."
What is the current cohort size of this research study?
"Unfortunately, this research trial is no longer seeking participants. The study was initially posted on December 6th 2019 and underwent its last edit November 17th 2022. For those still searching for trials to join, there are presently 1532 studies actively recruiting patients with leukemia or myelocytic acute conditions, as well as 273 clinical trials concerning Gilteritinib that need applicants."
Are there any other prior experiments that have assessed the efficacy of Gilteritinib?
"As of now, 68 Gilteritinib trials have reached Phase 3 with a total of 273 clinical studies in progress. While the majority are located in New york City, there exists 12991 sites across the world that are conducting research on this medication."
What are the eligibility requirements for participation in this trial?
"This medical trial seeks 181 participants afflicted with acute myelocytic leukemia aged between 18 and 70. Candidates must satisfy the following essential criteria: sign a Prescreening Consent for centralized testing of bone marrow/peripheral blood, have untreated FLT3 mutated Non M3 AML, commence standard of care induction 7+3 chemotherapy using same regimen and doses as defined in protocol while awaiting prescreening test results, not have received hypomethylating agent within 21 days prior to enrollment or exhibit known active Central Nervous System (CNS) leukemia."
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