RecruitingPhase 1/2

The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation

China66 participantsStarted 2024-10-08

Plain-language summary

The FMS tyrosine kinase 3 (FLT3) gene mutation occurs in 30% of newly diagnosed AML patients, leading to a higher relapse rate and mortality rate. In the past, multi-drug combination chemotherapy regimens had limited efficacy in newly diagnosed AML patients with FLT3 mutations, especially in those with FLT3-ITD. However, the FLT3 inhibitors greatly improved the survival of AML patients with FLT3 mutations. Although several studies have focused on the effectiveness of FLT3 inhibitor combination therapy for FLT3-mutated AML, further studies are needed to determine the optimal regimen and dosage. A triple regimen consisting of Gilteritinib, Venetoclax, and Azacitidine had shown good efficacy in unfit newly diagnosed FLT3-mutated AML patients. This clinical trial aims to determine the optimal triple regimen and investigate its efficacy in newly diagnosed fit FLT3-mutated AML patients.

Who can participate

Age range

14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. MDS/AML patients WHO meet AML and ICC definitions according to WHO (2022) or ICC standards (10%-20% of bone marrow naive cells) and have FLT3-TKD or ITD mutations detected by PCR or second-generation sequencing.
. Age ≥15 years old, male or female.
. The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
. Pass the requirements of the following laboratory tests (performed within 7 days before treatment) :

Exclusion criteria

. Acute promyelocytic leukemia with PML-RARA fusion gene
. Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite Complete remission (CRc) rate

Timeframe: up to 3 months after the date of the last enrolled participants

Composite Complete remission (CRc) with negative MRD detected by flow cytometry.

Timeframe: up to 1 years after the date of the last enrolled participants

To determine the tolerated dose of triple regimens

Timeframe: up to 3 months after enrollment of the first participants

Event-free survival (EFS)

Timeframe: up to 2 years after the date of the last enrolled participants

Trial details

NCT IDNCT06561880

SponsorInstitute of Hematology & Blood Diseases Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

Contact for this trial

Hui Wei, Doctor

13132507161 weihui@ihcams.ac.cn

View on ClinicalTrials.gov More FLT3 Gene Mutation trials