AML (Acute Myeloid Leukemia)Phase 2/3FIT-AMLNCT07425808
FLT3-ITD Targeted Therapy in Fit AML Patients
A Phase 2/3 study testing Gilteritinib, Venetoclax and Azacitidine (AZA) in people with AML (Acute Myeloid Leukemia), run by European Organisation for Research and Treatment of Cancer - EORTC.
Trial summary
This international, multicenter, randomized (1:1), open-label phase II/III trial will evaluate the efficacy and safety of gilteritinib combined with azacitidine and venetoclax (experimental arm) versus standard "7+3" induction plus a FLT3inhibitor (quizartinib or midostaurin) (control arm) in newly diagnosed FLT3-ITD… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- AML (Acute Myeloid Leukemia)
- What is being tested?
- Gilteritinib, Venetoclax and Azacitidine (AZA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Feb 2032
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed AML cytopathologically confirmed according to the 5th WHO classification
- Age between 18 and 75 years
- FLT3-ITD mutation as per local IVDR-compliant testing. Positivity is defined as a FLT3-ITD / FLT3-wild type (WT) ratio of ≥ 0.05 (5%))
- Eligibility for standard induction chemotherapy
- ECOG PS ≤ 2
- WBC ≤25 x 10^9/L (hydroxyurea, leukapheresis or cytarabine in specific clinical circumstances, are allowed to meet this criterion. Please refer to Section 4.1.1 - Inclusion Criteria).
Show all 27Show fewer
- Adequate hepatic function (as indicated by total serum bilirubin level ≤2.5 x the institutional upper limit of normal range (UNL), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the investigator; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤3 x UNL)
- Adequate renal function as defined by an eGFR ≥ 30 mL/min according to the 2021 CKD-EPI equation
- Main Exclusion Criteria:
- Acute promyelocytic leukemia (APL)
- BCR-ABL positive leukemia or Ph1-positive chronic myeloid leukemia
- History of myeloproliferative neoplasm (MPN), including myelofibrosis, essential thrombocythemia, polycythemia vera
- Active central nervous system involvement by AML
- Active, uncontrolled infection (viral, bacterial or fungal): an infection controlled with an approved or closely monitored antibiotic/antifungal treatment is allowed.
- HIV, HBV or HCV active infection
- Grade >3 CTCAE (v. 6) clinically relevant (as per local investigator) adverse events at the time of enrolment
- Prior treatment for myelodysplastic syndrome (MDS) with Venetoclax or hypomethylating agents (decitabine, azacitidine).
- Any prior AML therapies (except for emergency treatment with hydroxyurea or cytarabine for hyperleukocytosis) Note: Subjects who undergo diagnostic workup for APL and treatment with all-trans retinoic acid, but who are found not to have APL, are eligible (treatment with all-trans retinoic acid must be discontinued before starting induction chemotherapy).
- Any prior treatment with a FLT3 inhibitor
- Serious organ dysfunction as left ventricular ejection fraction <40%, FEV1, FVC, DLCO (diffusion capacity) <40% of predicted
- Cardiovascular disability status of New York Heart Association class ≥ 2
- Congenital long QT syndrome or QT Interval Corrected Using Fridericia's Formula (QTcF) >450 msec Note: repeat electrocardiograms after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria. In cases where QTcF >450 msec is considered to be falsely increased due to inaccurate automated reading and not clinically significant (e.g. due to bundle branch block), patients are still eligible if cardiologist reviews and documents that QTcF is ≤ 450 msec when manually measured.
- Participant with a prior or concurrent malignancy or autoimmune disease requiring immunosuppressive therapy.
- Note: diseases whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the 2467 medical monitor and the study coordinator.
- Consumed strong or moderate inducers of Cytochrome P450, family 3, subfamily A (CYP3A) or p-glycoprotein within 14 days of study enrolment or requiring treatment with such a medication during the trial.
- Inability to swallow and/or any gastrointestinal disorders, malabsorption or other abnormalities that would interfere with absorption of the oral study drug.
- Other life-threatening concurrent disease.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Gilteritinib in Combination With Azacitidine and Venetoclax Compared to Induction Chemotherapy "7+3" in Combination With a FLT3-inhibitor in Fit, Newly Diagnosed, FLT3-ITD Mutated Adult AML Patients: a Randomized Trial of the EORTC Leukemia Group and GIMEMA.
This international, multicenter, randomized (1:1), open-label phase II/III trial will evaluate the efficacy and safety of gilteritinib combined with azacitidine and venetoclax (experimental arm) versus standard "7+3" induction plus a FLT3inhibitor (quizartinib or midostaurin) (control arm) in newly diagnosed FLT3-ITD mutated AML patients eligible for intensive chemotherapy.
Read the detailed description
Newly diagnosed AML patients deemed fit by the investigator to receive intensive chemotherapy will be screened for FLT3-ITD mutation. Eligible patients will be randomized in a 1:1 ratio between experimental and control arms, stratified by age and WBC at diagnosis:
- Participants assigned to the experimental arm will receive a triplet regimen consisting of VEN, AZA, and gilteritinib, administered for up to 12 cycles. This will be followed by up to 12 additional cycles of AZA in combination with gilteritinib, and subsequently up to 12 cycles of gilteritinib monotherapy
- Participants in the control arm will be treated following the local standard of care, consisting of induction with '7+3', consolidation with high-dose cytarabine, and maintenance with a FLT3 inhibitor (midostaurin, quizartinib, or sorafenib) as per local practice.
Participants in the experimental arm with an available donor should proceed to HSCT based on the local investigator's judgement, but this should not occur prior to the end of cycle 2. For participants in the control group, HSCT is as per the local investigator's judgement, but recommended in first CR/CRi.
For patients with no available donor and not proceeding to HSCT, treatment in the experimental arm is recommended to continue for a minimum of 6 cycles before transitioning to maintenance treatment with AZA and gilteritinib.
Following HSCT, patients in the experimental arm will receive gilteritinib maintenance for up to 36 cycles and in the control arm, FLT3-inhibitor as per local standard of care (i.e., midostaurin, quizartinib or sorafenib).
- Conditions
- AML (Acute Myeloid Leukemia)
- Being tested
- Gilteritinib, Venetoclax, Azacitidine (AZA), Local standard of care (SOC)
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GilteritinibDrug
Cycle 1: 80 mg once daily orally on days 1-28. Cycle 2 - 12: 80mg once daily orally on days 1-28. Cycle 13 - 24: gilteritinib 120 mg once daily orally on days 1-28. Following HSCT, maintenance with gilteritinib (120 mg once daily orally on days 1-28) will be offered for up to 36 cycles and started between day 30 and 90 after hematopoietic stem-cell transplantation (HSCT).
VenetoclaxDrug
Cycle 1: ramp-up from 100mg on day 1, 200 mg on day 2 and 400 mg on days 3 - 28.
Cycle 2 - 12: venetoclax 400 mg once daily orally days 1-7.
Azacitidine (AZA)Drug
Cycle 1: 75 mg/m² once daily subcutaneously on days 1-7. Cycle 2 -12: 75 mg/m² once daily subcutaneously on days 1-5. Cycle 13 - 24: 75 mg/m² once daily subcutaneously on days 1-5.
Local standard of care (SOC)Drug
Local SOC is "7+3" + Midostaurin (100 mg) or Quizartinib (35.4 mg)
| Study group | Role | What they receive |
|---|---|---|
| Triplet combination of venetoclax, azacitidine and gilteritinib | Experimental | Triplet regimen consisting of venetoclax, azacitidine and gilteritinib, administered for up to 12 cycles (28-day cycles). This will be followed by up to 12 additional cycles of azacitidine in combination with gilteritinib (28-day cycles). Receives: Drug: Gilteritinib; Drug: Venetoclax; Drug: Azacitidine (AZA) |
| Local standard of care | Active comparator | Local standard of care, consisting of induction with '7+3', consolidation with high-dose cytarabine, and maintenance with a FLT3 inhibitor (midostaurin, quizartinib, or sorafenib) as per local practice. Receives: Drug: Local standard of care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II: Achievement of CR/CRi documented within 6 months from randomization, occurring prior to allografting and before initiation of any post-protocol treatments.
The European LeukemiaNet (ELN) 2022 criteria will be used to evaluate CR/CRi.
Measured: Within 6 months from randomization
Phase III: Overall survival
Measured: From baseline through study completion, an average of 7 years
Secondary outcomes (11)
Achievement of CR/CRi documented within 6 months from randomization, occurring prior to allografting and before initiation of any post-protocol treatments (for the phase III component of the trial only)
Measured: Within 6 months from randomization
Overall survival (for the phase II component of the trial only)
Measured: From baseline through study completion, an average of 7 years
Event-free survival
Event-free survival defined as the time between the date of randomization and the date of relapse, treatment failure or death, whichever occurs first
Measured: From baseline through study completion, an average of 7 years
Incidence of adverse events
Measured: From baseline through study completion, an average of 7 years
Deterioration from baseline by ≥10 points in global health status measured by EORTC QLQ-C30
Measured: Weeks 1, 2, 3, 4, 10, and month 6, 12, and 30 from randomization
Deterioration from baseline by ≥10 points in physical functioning measured by EORTC QLQ-C30
Measured: Weeks 1, 2, 3, 4, 10 and month 6, 12 and 30 from randomization
Deterioration from baseline by ≥10 points in role functioning measured by EORTC QLQ-C30
Measured: Weeks 1, 2, 3, 4, 10 and month 6, 12 and 30 from randomization
Deterioration from baseline by ≥10 points in fatigue measured by EORTC QLQ-C30
Measured: Weeks 1, 2, 3, 4, 10, and month 6, 12, and 30 from randomization
Deterioration from baseline by ≥10 points in pain measured by EORTC QLQ-C30
Measured: Weeks 1, 2, 3, 4, 10, and month 6, 12, and 30 from randomization
High burden of treatment ("Quite a bit" / "Very much") measured by item Q168 from IL471
Measured: Weeks 1, 2, 3, 4, 10, and month 6, 12, and 30 from randomization
High burden of illness ("Quite a bit" / "Very much") measured by item Q46 from IL471
Measured: Weeks 1, 2, 3, 4, 10, and month 6, 12, and 30 from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myeloid Leukemia)Studies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- Fondazione GIMEMA, Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Christoph Rummelt, MD, PhD, Principal investigator, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425808
- Sponsor's protocol ID
- EORTC 2467-LG
- Acronym
- FIT-AML
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gilteritinib in Combination With Azacitidine and Venetoclax Compared to Induction Chemotherapy "7+3" in Combination With a FLT3-inhibitor in Fit, Newly Diagnosed, FLT3-ITD Mutated Adult AML Patients: a Randomized Trial of the EORTC Leukemia Group and GIMEMA.
- ClinicalTrials.gov ID
- NCT07425808
- Acronym / sponsor ID
- FIT-AML / EORTC 2467-LG
- Conditions
- AML (Acute Myeloid Leukemia)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- Fondazione GIMEMA, Astellas Pharma Inc
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Feb 2032 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This international, multicenter, randomized (1:1), open-label phase II/III trial will evaluate the efficacy and safety of gilteritinib combined with azacitidine and venetoclax (experimental arm) versus standard "7+3" induction plus a FLT3inhibitor (quizartinib or midostaurin) (control arm) in newly diagnosed FLT3-ITD mutated AML patients eligible for intensive chemotherapy.
Detailed description
Newly diagnosed AML patients deemed fit by the investigator to receive intensive chemotherapy will be screened for FLT3-ITD mutation. Eligible patients will be randomized in a 1:1 ratio between experimental and control arms, stratified by age and WBC at diagnosis:
- Participants assigned to the experimental arm will receive a triplet regimen consisting of VEN, AZA, and gilteritinib, administered for up to 12 cycles. This will be followed by up to 12 additional cycles of AZA in combination with gilteritinib, and subsequently up to 12 cycles of gilteritinib monotherapy
- Participants in the control arm will be treated following the local standard of care, consisting of induction with '7+3', consolidation with high-dose cytarabine, and maintenance with a FLT3 inhibitor (midostaurin, quizartinib, or sorafenib) as per local practice.
Participants in the experimental arm with an available donor should proceed to HSCT based on the local investigator's judgement, but this should not occur prior to the end of cycle 2. For participants in the control group, HSCT is as per the local investigator's judgement, but recommended in first CR/CRi.
For patients with no available donor and not proceeding to HSCT, treatment in the experimental arm is recommended to continue for a minimum of 6 cycles before transitioning to maintenance treatment with AZA and gilteritinib.
Following HSCT, patients in the experimental arm will receive gilteritinib maintenance for up to 36 cycles and in the control arm, FLT3-inhibitor as per local standard of care (i.e., midostaurin, quizartinib or sorafenib).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triplet combination of venetoclax, azacitidine and gilteritinib | Experimental | Drug: Gilteritinib, Drug: Venetoclax, Drug: Azacitidine (AZA)Triplet regimen consisting of venetoclax, azacitidine and gilteritinib, administered for up to 12 cycles (28-day cycles). This will be followed by up to 12 additional cycles of azacitidine in combination with gilteritinib (28-day cycles). |
| Local standard of care | Active comparator | Drug: Local standard of care (SOC)Local standard of care, consisting of induction with '7+3', consolidation with high-dose cytarabine, and maintenance with a FLT3 inhibitor (midostaurin, quizartinib, or sorafenib) as per local practice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Newly diagnosed AML cytopathologically confirmed according to the 5th WHO classification
- Age between 18 and 75 years
- FLT3-ITD mutation as per local IVDR-compliant testing. Positivity is defined as a FLT3-ITD / FLT3-wild type (WT) ratio of ≥ 0.05 (5%))
- Eligibility for standard induction chemotherapy
- ECOG PS ≤ 2
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GilteritinibCycle 1: 80 mg once daily orally on days 1-28. Cycle 2 - 12: 80mg once daily orally on days 1-28. Cycle 13 - 24: gilteritinib 120 mg once daily orally on days 1-28. Following HSCT, maintenance with gilteritinib (120 mg once daily orally on days 1-28) will be offered for up to 36 cycles and started between day 30 and 90 after hematopoietic stem-cell transplantation (HSCT). | Drug | Triplet combination of venetoclax, azacitidine and gilteritinib |
| VenetoclaxCycle 1: ramp-up from 100mg on day 1, 200 mg on day 2 and 400 mg on days 3 - 28. Cycle 2 - 12: venetoclax 400 mg once daily orally days 1-7. | Drug | Triplet combination of venetoclax, azacitidine and gilteritinib |
| Azacitidine (AZA)Cycle 1: 75 mg/m² once daily subcutaneously on days 1-7. Cycle 2 -12: 75 mg/m² once daily subcutaneously on days 1-5. Cycle 13 - 24: 75 mg/m² once daily subcutaneously on days 1-5. | Drug | Triplet combination of venetoclax, azacitidine and gilteritinib |
| Local standard of care (SOC)Local SOC is "7+3" + Midostaurin (100 mg) or Quizartinib (35.4 mg) | Drug | Local standard of care |
Primary outcome
Phase II: Achievement of CR/CRi documented within 6 months from randomization, occurring prior to allografting and before initiation of any post-protocol treatments.
Time frame: Within 6 months from randomization
The European LeukemiaNet (ELN) 2022 criteria will be used to evaluate CR/CRi.
Phase III: Overall survival
Time frame: From baseline through study completion, an average of 7 years
11 secondary outcomes
Achievement of CR/CRi documented within 6 months from randomization, occurring prior to allografting and before initiation of any post-protocol treatments (for the phase III component of the trial only)
Time frame: Within 6 months from randomization
Overall survival (for the phase II component of the trial only)
Time frame: From baseline through study completion, an average of 7 years
Event-free survival
Time frame: From baseline through study completion, an average of 7 years
Incidence of adverse events
Time frame: From baseline through study completion, an average of 7 years
Deterioration from baseline by ≥10 points in global health status measured by EORTC QLQ-C30
Time frame: Weeks 1, 2, 3, 4, 10, and month 6, 12, and 30 from randomization
Deterioration from baseline by ≥10 points in physical functioning measured by EORTC QLQ-C30
Time frame: Weeks 1, 2, 3, 4, 10 and month 6, 12 and 30 from randomization
Deterioration from baseline by ≥10 points in role functioning measured by EORTC QLQ-C30
Time frame: Weeks 1, 2, 3, 4, 10 and month 6, 12 and 30 from randomization
Deterioration from baseline by ≥10 points in fatigue measured by EORTC QLQ-C30
Time frame: Weeks 1, 2, 3, 4, 10, and month 6, 12, and 30 from randomization
Deterioration from baseline by ≥10 points in pain measured by EORTC QLQ-C30
Time frame: Weeks 1, 2, 3, 4, 10, and month 6, 12, and 30 from randomization
High burden of treatment ("Quite a bit" / "Very much") measured by item Q168 from IL471
Time frame: Weeks 1, 2, 3, 4, 10, and month 6, 12, and 30 from randomization
High burden of illness ("Quite a bit" / "Very much") measured by item Q46 from IL471
Time frame: Weeks 1, 2, 3, 4, 10, and month 6, 12, and 30 from randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christoph Rummelt, MD, PhD principal investigator
University Hospital Freiburg
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gilteritinib, Venetoclax and Azacitidine (AZA) in people with AML (Acute Myeloid Leukemia), run by European Organisation for Research and Treatment of Cancer - EORTC.
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 27 inclusion and 0 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 23 Feb 2026. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 EORTC HQ (+32 2 774611, eortc@eortc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II: Achievement of CR/CRi documented within 6 months from randomization, occurring prior to allografting and before initiation of any post-protocol treatments. (time frame: Within 6 months from randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2026.