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AzTrials

Acute Myeloid LeukemiaPhase 2NCT06667973

Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia

A Phase 2 study testing Gilteritinib in people with Acute Myeloid Leukemia and FLT3 Gene Mutation, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to evaluate the efficacy of gilteritinib as induction therapy in FLT3-positive adult acute myeloid leukemia patients. The main question it aims to answer is: Is gilteritinib in combination to chemotherapy able to improve the complete remission rate of FLT3-positive AML? Participants… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Gilteritinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
Jun 2025to Jun 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient is ≥ 18 and ≤65 years old.
  • The patient has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 to 2.
  • The patient has adequate baseline organ function, including cardiac, renal, and hepatic function:
  • Left ventricular ejection fraction (LVEF) ≥institutional lower limit of normal as measured by multigated acquisition (MUGA) scan or 2-dimensional (2-D) echocardiography (ECHO) within 21 days before start of therapy and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG).
  • ECG: QTcF≤450 male ≤480 female
  • Serum creatinine ≤ 1.5 x ULN or an estimated glomerular filtration rate of > 50 mL/min as calculated by the Modification of Diet in Renal Disease equation.
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  • Bilirubin ≤3 times the upper limit of normal ULN mg/dL except for Gilbert's condition
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)., except if due to leukemic involvement.
  • Patient is positive at diagnosis for FLT3 activating mutation in bone marrow or whole blood.
  • Diagnosis of untreated AML according to WHO 2016, non-APL
  • If the patient is a woman of childbearing potential (WOCBP), she must have a negative serum or urine pregnancy test at screening within 1 week before treatment.
  • The patient (male and female) agrees to use two acceptable contraceptive methods for the duration of time on the study and continue to use acceptable contraceptive methods for 6 months after the end of treatment
  • The patient has signed informed consent before initiation of any study-specific procedures or treatment.
  • The patient is able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment

Who cannot join

  • Patient was diagnosed as acute promyelocytic leukemia.
  • Patient has BCR-ABL-positive leukemia or chronic myelogenous leukemia in blast crisis.
  • Patient has clinically active central nervous system leukemia.
  • Patient has been diagnosed with another malignancy, unless disease-free for at least 3 years. Subjects with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, papillary thyroid carcinoma, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Subjects with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed or treated with definitive radiotherapy.
  • Patient has had major surgery within 4 weeks prior to the first study dose.
  • Patient has radiation therapy within 4 weeks prior to the first study dose.
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  • Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4 or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 1 month prior to study entry results in a left ventricular ejection fraction that is ≥ 45%.
  • Patient has an active uncontrolled infection.
  • Patient has active human immunodeficiency virus infection.
  • Patient has active hepatitis B or C or other active hepatic disorder. Chronic conditions previously cured or in active prophylaxis are allowed in the study
  • Patient has infections, comorbidities or any disease, condition or alteration that per judgment of the investigator may be jeopardized by therapy
  • Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy with the exception of Hydroxyurea (HU) or 6-Mercaptopurine (6MP) in patients who need to continue this agent to maintain WBC count ≤10,000/mm3. HU and 6MP must be discontinued at the time of initiation of study medications.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Paola Fazi contact

0670390528

p.fazi@gimema.it

Enrico Crea contact

0670390514

e.crea@gimema.it

About this study

Official title: A Phase 2, Open-label, Multicentre Study Investigating Tolerability and Efficacy of Gilteritinib in Combination With Fludarabine, Cytarabine and Idarubicin (FLAI) as Induction Therapy of Newly Diagnosed Non-M3 FLT3-positive Acute Myeloid Leukemia

The goal of this clinical trial is to evaluate the efficacy of gilteritinib as induction therapy in FLT3-positive adult acute myeloid leukemia patients. The main question it aims to answer is:

Is gilteritinib in combination to chemotherapy able to improve the complete remission rate of FLT3-positive AML?

Participants will receive up to 2 induction cycles with gilteritinib in combination with FLAI (fludarabine, cytarabine, idarubicine) and up to 3 consolidation cycles with gilteritinib and high-dose cytarabine.

Read the detailed description

This is a multi-center, non-controlled, open-label, Phase 2 interventional study.

Young (≤65 years old) patients with newly diagnosed non M3, FLT3-positive acute myeloid leukemia will receive a combination of Gilteritinib and FLAI (fludarabine, high dose cytarabine and idarubicin) as induction treatment.

Gilteritinib will be administered at the standard dose of 120 mg which has already been tested in phase I combination trials. (34) Patients failing to achieve CR after first cycle may receive a second identical induction with FLAI.

Patients achieving CR after the first cycle of FLAI may receive, upon medical decision, a second induction as well, however omitting fludarabine administration (high dose cytarabine + idarubicin).

Consolidation treatment will consist in up to 3 cycles of high dose cytarabine in combination with Gilteritinib.

Transplant will be allowed in the trial for eligible patients. The primary endpoint is CR rate after first FLAI (or after second FLAI if administered).

Key secondary endpoint is MRD negativity rate after first FLAI (or after second FLAI if administered).

As the achievement of CR in AML is required for long term survival, the primary endpoint is of high clinical significance. Furthermore, given the well-known prognostic impact of MRD in CR patients, the key secondary endpoint is also highly relevant.

Planned study duration is 60 months. Patient enrollment is expected to be completed in 3 years, and the last patient enrolled will be followed-up for 18 months.

Being tested
Gilteritinib
Medical subject headings
Leukemia, Myeloid, Acute, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GilteritinibDrug

    Gilteritinib fumarate is an oral, selective FLT3 and AXL inhibitor. It is a type 1 inhibitor, active against both the FLT3-ITD and FLT3-TKD mutations. Gilteritinib inhibits FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3-ITD, FLT3-D835Y, and FLT3-ITD-D835Y, and it induces apoptosis in leukemic cells expressing FLT3-ITD.

    Gilteritinib is approved for the treatment of relpased/refractory FLT3-mutated AML after the successfull ADMIRAL trial. In the present study Gilteritinib (120 mg/die) in combination with FLAI will be tested as induction therapy in newly-diagnosed patients.

Study groups in NCT06667973
Study groupRoleWhat they receive
Newly-diagnosed FLT3-positive Acute Myeloid Leukemia treated with gilteritinibExperimentalTreatment consists in up to 2 induction cycles and up to 3 consolidation cycles: Induction: Patients will receive Gilteritinib 120 mg QD p.o from day 6 to 26 (21 days), in combination with FLAI induction (fludarabine 30 mg/sqm from day 1 to 5, cytarabine 2000 mg/sqm from day 1 to 5, Idarubicine 10 mg/sqm on days 1, 3, 53). Response will be assessed on day 28 with a bone marrow aspirate. * In patients not achieving CR, the second induction cycle will be identical to Induction I. * In patients achieving CR, a second induction cycle with ARA-C + IDA will be allowed (cytarabine 2000 mg/sqm from day 1 to 5, Idarubicine 10 mg/sqm on days 1, 3, 5), with the same schedule for Gilteritinib (day 6 to 26) Up to 3 consolidation cycles consisting in high dose cytarabine (1500-3000 mg/sqm bid on days 1,3,5) or intermediate in combination with Gilteritinib 120 mg QD p.o from day 6 to 26 will be allowed. Patients considered eligible may proceed to allo-HSCT at any time after day 28.
Receives: Drug: Gilteritinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete remission rate after induction

    Number of patients who achieve a CR after course 1 or course 2 if adiministered on the total of evaluable patients

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2024
  2. Study startJun 2025 (estimated)
  3. Primary completionAug 2028 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06667973
Sponsor's protocol ID
AML2924
Status last verified
Mar 2025
First submitted
30 Oct 2024
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gilteritinib in people with Acute Myeloid Leukemia and FLT3 Gene Mutation, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission rate after induction (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06667973.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

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