Acute Myeloid Leukemia (AML)Phase 3TROPHY-15NCT07463651
MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib
A Phase 3 study testing Gilteritinib and Sorafenib in people with Acute Myeloid Leukemia (AML) and FLT3-ITD Mutation, run by The First Affiliated Hospital of Soochow University at 2 sites in China.
Trial summary
The study population consisted of FLT3-ITD-mutated AML patients who were FLT3-ITD-positive before allogeneic hematopoietic stem cell transplantation. This open-label, randomized, controlled trial enrolled participants and randomly assigned them in a 1:1 ratio to either the experimental group or the control group. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML), FLT3-ITD Mutation, Allogeneic Hematopoietic Cell Transplantation (HCT)
- What is being tested?
- Gilteritinib and Sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2026to 31 Mar 2030
- Phase
- Phase 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent and willingness to participate in this clinical study;
- Gender is not limited, age range is 14-70 years old (including threshold);
- ECOG score 0-2 points;
- Diagnosed with AML through bone marrow morphology, immunology, cytogenetics, and molecular biology (MICM) typing, and confirmed to have FLT3-ITD mutation;
- Successfully accepted allo HSCT, with no restrictions on the pre-treatment protocol, allowing any donor source [fully matched cell, unrelated donor (URD), incompatible unrelated donor, haploidentical relative donor or umbilical cord blood], allowing any graft source [umbilical cord blood, bone marrow (BM), peripheral blood (PB)]; ⑥ Patients with complete morphological remission (CR) prior to allo HSCT, and FLT3-ITD MRD positivity detected by PCR-NGS within 30 days prior to allo HSCT (defined as FLT3-ITD transcript level ≥ 10 - 6);
- ⑦ After transplantation: hematopoietic function implantation (ANC ≥ 500/μ L, platelet count ≥ 20000/μ L and not dependent on infusion), oral administration of investigational drugs, exclusion of overlap syndrome, complete donor chimerism (FDC) status, no activity requiring daily prednisone dose>0.5 mg/kg, acute GVHD;
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- ⑧ Clinical laboratory tests meet the following criteria: a. Serum creatinine ≤ 2.0 times the upper limit of normal value; b. Total bilirubin ≤ 2.5 mg/dL (excluding Gilbert syndrome patients); c. Serum AST and/or ALT<3 times the upper limit of normal values;
- ⑨ Maintenance treatment should be started 60 to 90 days after transplantation;
- ⑩ Female participants must meet the following criteria: have undergone menopause (at least 1 year without menstruation) or surgical sterilization (at least 1 month ago) before screening for infertility; Or have the ability to conceive but agree not to plan pregnancy during the study period and within 6 months after the last dose; Conduct pregnancy tests during the screening period; If there is heterosexual behavior, agree to continue using local standard high-efficiency contraceptive measures plus barrier method from the beginning of screening to 6 months after the last administration; Agree not to breastfeed or donate eggs during the study period and for 6 months after the last administration Male participants must meet the following requirements: male participants (even if sterilized) and their reproductive partners must use efficient contraception plus barrier method during the study period and within 127 days after the last dose; Male participants are not allowed to donate sperm during the study period and for 127 days after the last dose;
Who cannot join
- Allergies to Girotinib or Sorafenib, as well as any components of the therapeutic drugs used during the study period;
- Any serious comorbidities that make patients unsuitable for participation in this study or may affect protocol compliance;
- FLT3-ITD molecular MRD positivity before maintenance therapy;
- Severe organ dysfunction such as organ failure occurs after allogeneic hematopoietic stem cell transplantation;
- Subjects who are positive for hepatitis B B surface antigen (HBsAg) and whose hepatitis B virus (HBV) DNA titer is higher than the upper limit of the normal value range of the research center, and who are judged by the researchers not suitable for this study; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; Individuals who are HIV antibody positive; Positive syphilis test results;
- ⑥ There is evidence within the first 6 months of enrollment that the patient has other diseases or physiological conditions that may interfere with the evaluation results of this trial, or complications that seriously endanger life, including but not limited to uncontrolled infections, pulmonary arterial hypertension, severe heart failure (NYHA grades III and IV), unstable angina or acute myocardial infarction, poorly controlled refractory hypertension (based on hospitalization medical records diagnosis), etc;
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- ⑦ Individuals with mental or neurological disorders who are unable to express their wishes correctly;
- ⑧ Individuals who have had active malignant solid tumors within the past 5 years prior to participating in this study, except for cervical cancer, localized prostate cancer in situ, and non melanoma skin cancer that have been cured;
- ⑨ Have participated in or are currently participating in other clinical trials within one month prior to enrollment;
- ⑩ Researchers have determined that individuals are not suitable to participate in this clinical trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Xiaoxia Hu, M.D., Ph.D., +862164370045, hxx12276@rjh.com.cn
Xiaoxia Hu, M.D., Ph.D.
- Recruiting
the First Affiliated Hosptital of Soochow University
Suzhou, Jiangsu, 215006
Jia Chen, M.D., Ph.D., +8651267781856, drchenjia@163.com
Jia Chen, M.D., Ph.D.
About this study
Official title: Post-transplant Optimization Based on Ultra-high Sensitivity MRD Detection: A Prospective, Randomized Controlled Study Comparing Gilteritinib Versus Sorafenib as Post-transplant Maintenance Therapy in FLT3-ITD Mutation-positive Acute Myeloid Leukemia Patients
The study population consisted of FLT3-ITD-mutated AML patients who were FLT3-ITD-positive before allogeneic hematopoietic stem cell transplantation. This open-label, randomized, controlled trial enrolled participants and randomly assigned them in a 1:1 ratio to either the experimental group or the control group. The experimental group received maintenance therapy with gilteritinib, while the control group received maintenance therapy with sorafenib, with 297 cases in each group, totaling 594 enrolled subjects.
All patients' minimal residual disease (MRD) testing was sent to the designated central laboratory and uniformly performed using the PCR-NGS method to ensure consistency and comparability of the test results.
Study Visits: This study includes a screening period (within 30 days prior to HCT) and a 2-year treatment phase, with efficacy and safety follow-up until death, withdrawal of informed consent, or 2 years after the first administration of treatment, whichever occurs first.
- Conditions
- Acute Myeloid Leukemia (AML), FLT3-ITD Mutation, Allogeneic Hematopoietic Cell Transplantation (HCT), Maintenance Therapy, Gilteritinib, Sorafenib
- Being tested
- Gilteritinib, Sorafenib
- Keywords
- Acute Myeloid Leukemia, FLT3-ITD Mutation, Allogeneic Hematopoietic Cell Transplantatio, Maintenance therapy, Gilteritinib, sorafeni
- 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
Randomization should be performed between days 60 and 90 after the day of allogeneic hematopoietic stem cell infusion (day 0 post-HCT). Participants allocated in this arm must take Gilteritinib 3 tablets (40 mg per tablet) daily in the morning, with continuous daily administration.
SorafenibDrug
Randomization should be performed between days 60 and 90 after the day of allogeneic hematopoietic stem cell infusion (day 0 post-HCT). Participants allocated in this arm must take sorafenib 400 mg orally, twice daily (BID), with continuous administration
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Randomization should be performed between days 60 and 90 after the day of allogeneic hematopoietic stem cell infusion (day 0 post-HCT). Participants allocated in this arm must take Gilteritinib 3 tablets (40 mg per tablet) daily in the morning, with continuous daily administration Receives: Drug: Gilteritinib |
| Arm B | Active comparator | Randomization should be performed between days 60 and 90 after the day of allogeneic hematopoietic stem cell infusion (day 0 post-HCT). Participants allocated in this arm must take sorafenib 400 mg orally, twice daily (BID), with continuous administration Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurable residual disease recurrence-free survival (MRD-RFS)
The time from randomization to occurrence of hematological recurrence, molecular recurrence (FLT3-ITD mutation MRD changes from negative to positive), or death from any cause (whichever occurs first).
Measured: 2-year
Secondary outcomes (9)
Overall Surivival (OS)
The time from randomazation to death
Measured: 2-year
Molecular Recurrence
From random to MRD-positive detected by PCR NGS of FLT3-ITD mutation
Measured: 2-year
MFC-MRD Recurrence
From randomization to MRD-positive detected by MFC
Measured: 2-year
Cumulative Incidence of Relapse (CIR)
From randomization to relapse
Measured: 2-year
Non-Relapse Mortality (NRM)
From randomization to death unrelated to AML
Measured: 2-year
Chronic Graft-versus-Host Disease (cGVHD)
From randomization to the occurence of chronic graft-versus-host disease (cGVHD)
Measured: 2-year
Acute Graft-versus-Host Disease (aGVHD)
From randomization to the occurence of acute graft-versus-host disease (aGVHD)
Measured: 2-year
Graft-versus-Host Disease and Relapse-free survival (GRFS)
From randomization to the occurence of graft-versus-host disease (GVHD), relapse or death, which occurs first
Measured: 2-year
Relpase-Free Survival (RFS)
From randomization to the occurence of relapse or death, which occurs first
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 594 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHEN Jia, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463651
- Sponsor's protocol ID
- TROPHY-15
- Other IDs
- 2025D0545700
- Acronym
- TROPHY-15
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If required, IPD may be shared with approval of institutional ethic committee.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-transplant Optimization Based on Ultra-high Sensitivity MRD Detection: A Prospective, Randomized Controlled Study Comparing Gilteritinib Versus Sorafenib as Post-transplant Maintenance Therapy in FLT3-ITD Mutation-positive Acute Myeloid Leukemia Patients
- ClinicalTrials.gov ID
- NCT07463651
- Acronym / sponsor ID
- TROPHY-15 / TROPHY-15
- Conditions
- Acute Myeloid Leukemia (AML), FLT3-ITD Mutation, Allogeneic Hematopoietic Cell Transplantation (HCT), Maintenance Therapy, Gilteritinib, Sorafenib
- Keywords
- Acute Myeloid Leukemia, FLT3-ITD Mutation, Allogeneic Hematopoietic Cell Transplantatio, Maintenance therapy, Gilteritinib, sorafeni
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 594 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 11 Mar 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.
The study population consisted of FLT3-ITD-mutated AML patients who were FLT3-ITD-positive before allogeneic hematopoietic stem cell transplantation. This open-label, randomized, controlled trial enrolled participants and randomly assigned them in a 1:1 ratio to either the experimental group or the control group. The experimental group received maintenance therapy with gilteritinib, while the control group received maintenance therapy with sorafenib, with 297 cases in each group, totaling 594 enrolled subjects.
All patients' minimal residual disease (MRD) testing was sent to the designated central laboratory and uniformly performed using the PCR-NGS method to ensure consistency and comparability of the test results.
Study Visits: This study includes a screening period (within 30 days prior to HCT) and a 2-year treatment phase, with efficacy and safety follow-up until death, withdrawal of informed consent, or 2 years after the first administration of treatment, whichever occurs first.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: GilteritinibRandomization should be performed between days 60 and 90 after the day of allogeneic hematopoietic stem cell infusion (day 0 post-HCT). Participants allocated in this arm must take Gilteritinib 3 tablets (40 mg per tablet) daily in the morning, with continuous daily administration |
| Arm B | Active comparator | Drug: SorafenibRandomization should be performed between days 60 and 90 after the day of allogeneic hematopoietic stem cell infusion (day 0 post-HCT). Participants allocated in this arm must take sorafenib 400 mg orally, twice daily (BID), with continuous administration |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent and willingness to participate in this clinical study;
- ⑦ After transplantation: hematopoietic function implantation (ANC ≥ 500/μ L, platelet count ≥ 20000/μ L and not dependent on infusion), oral administration of investigational drugs, exclusion of overlap syndrome, complete donor chimerism (FDC) status, no activity requiring daily prednisone dose>0.5 mg/kg, acute GVHD;
- ⑧ Clinical laboratory tests meet the following criteria: a. Serum creatinine ≤ 2.0 times the upper limit of normal value; b. Total bilirubin ≤ 2.5 mg/dL (excluding Gilbert syndrome patients); c. Serum AST and/or ALT<3 times the upper limit of normal values;
- ⑨ Maintenance treatment should be started 60 to 90 days after transplantation;
- ⑩ Female participants must meet the following criteria: have undergone menopause (at least 1 year without menstruation) or surgical sterilization (at least 1 month ago) before screening for infertility; Or have the ability to conceive but agree not to plan pregnancy during the study period and within 6 months after the last dose; Conduct pregnancy tests during the screening period; If there is heterosexual behavior, agree to continue using local standard high-efficiency contraceptive measures plus barrier method from the beginning of screening to 6 months after the last administration; Agree not to breastfeed or donate eggs during the study period and for 6 months after the last administration Male participants must meet the following requirements: male participants (even if sterilized) and their reproductive partners must use efficient contraception plus barrier method during the study period and within 127 days after the last dose; Male participants are not allowed to donate sperm during the study period and for 127 days after the last dose;
Key exclusion criteria (10 listed)
- Allergies to Girotinib or Sorafenib, as well as any components of the therapeutic drugs used during the study period;
- ⑥ There is evidence within the first 6 months of enrollment that the patient has other diseases or physiological conditions that may interfere with the evaluation results of this trial, or complications that seriously endanger life, including but not limited to uncontrolled infections, pulmonary arterial hypertension, severe heart failure (NYHA grades III and IV), unstable angina or acute myocardial infarction, poorly controlled refractory hypertension (based on hospitalization medical records diagnosis), etc;
- ⑦ Individuals with mental or neurological disorders who are unable to express their wishes correctly;
- ⑧ Individuals who have had active malignant solid tumors within the past 5 years prior to participating in this study, except for cervical cancer, localized prostate cancer in situ, and non melanoma skin cancer that have been cured;
- ⑨ Have participated in or are currently participating in other clinical trials within one month prior to enrollment;
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 |
|---|---|---|
| GilteritinibRandomization should be performed between days 60 and 90 after the day of allogeneic hematopoietic stem cell infusion (day 0 post-HCT). Participants allocated in this arm must take Gilteritinib 3 tablets (40 mg per tablet) daily in the morning, with continuous daily administration. | Drug | Arm A |
| SorafenibRandomization should be performed between days 60 and 90 after the day of allogeneic hematopoietic stem cell infusion (day 0 post-HCT). Participants allocated in this arm must take sorafenib 400 mg orally, twice daily (BID), with continuous administration | Drug | Arm B |
Primary outcome
Measurable residual disease recurrence-free survival (MRD-RFS)
Time frame: 2-year
The time from randomization to occurrence of hematological recurrence, molecular recurrence (FLT3-ITD mutation MRD changes from negative to positive), or death from any cause (whichever occurs first).
9 secondary outcomes
Overall Surivival (OS)
Time frame: 2-year
Molecular Recurrence
Time frame: 2-year
MFC-MRD Recurrence
Time frame: 2-year
Cumulative Incidence of Relapse (CIR)
Time frame: 2-year
Non-Relapse Mortality (NRM)
Time frame: 2-year
Chronic Graft-versus-Host Disease (cGVHD)
Time frame: 2-year
Acute Graft-versus-Host Disease (aGVHD)
Time frame: 2-year
Graft-versus-Host Disease and Relapse-free survival (GRFS)
Time frame: 2-year
Relpase-Free Survival (RFS)
Time frame: 2-year
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 20 Mar 2026.
- Individual participant dataSharing planned: Undecided. If required, IPD may be shared with approval of institutional ethic committee.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gilteritinib and Sorafenib in people with Acute Myeloid Leukemia (AML) and FLT3-ITD Mutation, run by The First Affiliated Hospital of Soochow University at 2 sites in China.
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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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 Jia Chen, MD, PhD (+86-512-67781856, drchenjia@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurable residual disease recurrence-free survival (MRD-RFS) (time frame: 2-year). 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 20 Mar 2026.