ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATIONFLT3 - M vs RNCT07904884
MAC vs RIC for Transplantation in FLT3-ITD-Mutated AML Guided by UHS-NGS MRD ( FLT3 - MAC vs RIC )
A study testing RIC and MAC in people with ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION and Acute Myeloid Leukemia, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This is a multicenter, open-label, 1:1 randomized non-inferiority trial with stratification. The study will enroll patients aged 18-60 years with FLT3-ITD-mutated acute myeloid leukemia (AML) who are in first complete remission (CR1) and have no detectable FLT3-ITD measurable residual disease (MRD) by polymerase chain… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Acute Myeloid Leukemia
- What is being tested?
- RIC and MAC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 30 Sep 2029
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 to 60 years, any gender
- Diagnosis of AML according to WHO criteria
- Presence of FLT3-ITD mutation at diagnosis
- In first complete remission
- Planned first allogeneic hematopoietic stem cell transplantation using peripheral blood stem cells
- Planned post-transplant maintenance therapy with a FLT3 inhibitor (including sorafenib or gilteritinib)
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- FLT3-ITD UHS-NGS MRD < 0.001% at 14 to 28 days prior to transplantation
- Completion of routine pre-transplant assessments; in the investigator's judgment, the patient is able to complete the conditioning regimen, stem cell infusion, and study follow-up as planned;
- HCT-CI score of 0 to 2; in the investigator's judgment, the patient is eligible for either MAC or RIC conditioning intensity
- ECOG performance status at 0 to 2
- Estimated survival time ≥ 6 months
- Major organ function meets the following requirements: ALT and AST ≤2.5 × ULN; Total bilirubin ≤1.5 × ULN; subjects with Gilbert syndrome or elevated indirect bilirubin due to documented inactive hemolysis may be enrolled at the investigator's discretion; eGFR ≥30 mL/min/1.73 m², and not receiving maintenance dialysis; LVEF ≥50%, or cardiac function status determined by the investigator to be adequate to tolerate the study treatment; No requirement for high-flow oxygen therapy or mechanical ventilation support at rest
- Blood pressure is well-controlled; systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg at rest during the screening period; if receiving antihypertensive therapy, the dosage should be essentially stable prior to randomization
- Able to undergo assessments (including complete blood count, reticulocyte count, iron metabolism markers, adverse event monitoring, and transfusion records) as required by the protocol, and demonstrates good compliance
- Women of childbearing potential have a negative serum or urine pregnancy test; subjects of childbearing potential and their partners are willing to use effective contraceptive measures during the study and for the specified period following the last dose
- The subject or their legally authorized representative has signed a written informed consent form approved by the ethics committee prior to the implementation of any study-specific procedures
Who cannot join
- Prior allogeneic hematopoietic stem cell transplantation
- Achieved complete remission (CR) only after more than two cycles of induction therapy, or met the criteria for primary refractory AML
- Clear evidence of disease progression, relapse, or a need to immediately initiate new anti-tumor therapy prior to randomization, which could significantly impact the assessment of study endpoints
- Active central nervous system (CNS) leukemia
- Uncontrolled severe infection prior to randomization, including but not limited to: Sepsis or septic shock; Active invasive fungal infection; Bacterial or viral infection requiring escalation of broad-spectrum anti-infective therapy where the clinical condition remains unstable; Other severe infections deemed by the investigator to make the patient unsuitable for enrollment
- Concomitant high-risk cardiovascular or cerebrovascular conditions, including: Myocardial infarction, acute coronary syndrome, stroke, or transient ischemic attack within 6 months prior to randomization; Deep vein thrombosis, pulmonary embolism, or other clinically significant thromboembolic events within 6 months prior to randomization; New York Heart Association (NYHA) Class III-IV heart failure; Uncontrolled severe cardiac arrhythmia; Unacceptable thrombotic risk as determined by the investigator
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- Uncontrolled hypertension, defined as resting systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg despite optimized antihypertensive therapy
- Gastrointestinal disorders significantly affecting oral drug absorption or adherence (e.g., persistent vomiting, short bowel syndrome, active severe diarrhea, or other conditions judged by the investigator to significantly affect drug exposure), or inability to tolerate post-transplant FLT3 inhibitor maintenance therapy as determined by the investigator
- Pregnant or lactating women, or individuals unwilling to use effective contraceptive measures
- Participation in another interventional clinical trial involving treatment with an investigational drug or device within the 4 weeks prior to randomization, where the investigator determines that such participation might interfere with the results of this study
- Presence of uncontrolled psychiatric disorders, cognitive impairment, substance abuse, or other conditions that could affect informed consent, adherence, or safety follow-up
- Any other medical, laboratory, or social factors that, in the investigator's opinion, could increase the risk to the subject, affect study adherence, or interfere with the assessment of efficacy or safety
- Concurrent active malignancy; exceptions include: Malignancies that have been curatively treated with no evidence of recurrence within 5 years; Adequately treated basal cell carcinoma or squamous cell carcinoma of the skin; Treated carcinoma in situ determined by the investigator to have no impact on the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
YI YU, PhD contact
China1 site
The First Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang, Zhejiang, 310003
About this study
Official title: A Prospective, Multicenter, Open-label Randomized Trial Comparing Myeloablative vs Reduced-intensity Conditioning for Transplantation in FLT3-ITD-Mutated AML Guided by UHS-NGS MRD
This is a multicenter, open-label, 1:1 randomized non-inferiority trial with stratification. The study will enroll patients aged 18-60 years with FLT3-ITD-mutated acute myeloid leukemia (AML) who are in first complete remission (CR1) and have no detectable FLT3-ITD measurable residual disease (MRD) by polymerase chain reaction-next-generation sequencing (PCR-NGS) before allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Eligible patients will be randomly assigned to receive either reduced-intensity conditioning (RIC) or myeloablative conditioning (MAC) before allo-HSCT. All patients will receive FLT3 inhibitor maintenance therapy after transplantation.
The primary objective is to determine whether RIC is non-inferior to MAC in terms of 2-year relapse-free survival (RFS), defined as the time from transplantation to relapse or death from any cause. Secondary objectives include comparisons of overall survival (OS), non-relapse mortality (NRM), cumulative incidence of relapse, and graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS) between the two conditioning groups.
Read the detailed description
FLT3 internal tandem duplication (FLT3-ITD) is an adverse prognostic factor in acute myeloid leukemia (AML). Although allogeneic hematopoietic stem cell transplantation (allo-HSCT) and post-transplant FLT3 inhibitor maintenance have improved outcomes, relapse remains a major cause of treatment failure. Conditioning intensity is an important determinant of both relapse and non-relapse mortality (NRM), and the optimal conditioning strategy for patients with FLT3-ITD-mutated AML remains uncertain.
Previous studies have shown that myeloablative conditioning (MAC) can reduce relapse compared with reduced-intensity conditioning (RIC), particularly in patients with detectable measurable residual disease (MRD) before transplantation. However, the benefits of MAC must be balanced against its greater treatment-related toxicity. These findings suggest that pre-transplant MRD status may help identify patients who can achieve adequate disease control with less intensive conditioning. In addition, post-transplant FLT3 inhibitor maintenance provides an additional strategy for reducing relapse risk in patients with FLT3-ITD-mutated AML.
A retrospective study conducted by the Chinese TROPHY collaborative group evaluated 219 patients with FLT3-ITD-mutated AML undergoing allo-HSCT, most of whom received post-transplant FLT3 inhibitor maintenance. Among patients with detectable pre-transplant FLT3-ITD MRD by an ultrasensitive next-generation sequencing assay, RIC was associated with higher relapse incidence and inferior relapse-free survival (RFS) and overall survival (OS) than MAC. In contrast, outcomes were comparable between conditioning groups among patients with undetectable pre-transplant molecular MRD. These findings support further prospective evaluation of an MRD-guided conditioning strategy.
This multicenter, open-label, randomized non-inferiority trial will compare RIC with MAC in patients with FLT3-ITD-mutated AML who are in first complete remission and have no detectable pre-transplant FLT3-ITD MRD by polymerase chain reaction-next-generation sequencing (PCR-NGS). Participants will be randomly assigned to one of the two conditioning strategies, and all participants will receive FLT3 inhibitor maintenance after allo-HSCT. The study is designed to determine whether RIC provides comparable relapse-free survival to MAC in this molecularly defined population while potentially reducing conditioning-related toxicity and NRM. The results may help establish a prospective evidence base for integrating pre-transplant molecular MRD status and post-transplant maintenance therapy into individualized conditioning-intensity selection.
- Being tested
- RIC, MAC
- Keywords
- FLT3-mutated AML, Myeloablative Conditioning, Reduced-intensity conditioning, Ultra-high-sensitivity next-generation sequencing（UHS-NGS）
- 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.
RICProcedure or surgery
- Flu/Bu2 or Flu/Bu3: The total dose of fludarabine is 120-180 mg/m², and the total intravenous dose of busulfan is 6.4-9.6 mg/kg.
- Flu/Mel: The total dose of fludarabine is 120-180 mg/m², and the total dose of melphalan is 120-150 mg/m².
For the purposes of this study, Flu/Bu3 is included in the RIC group as a protocol-specified reduced-toxicity conditioning regimen.
MACProcedure or surgery
- Bu4/Cy2: The total intravenous dose of busulfan is 12.8 mg/kg, and the total dose of cyclophosphamide is 120 mg/kg.
- Bu4/Flu: The total intravenous dose of busulfan is 12.8 mg/kg, and the total dose of fludarabine is 120-180 mg/m².
- Modified Bu/Cy regimen: For patients undergoing haploidentical transplantation, a modified Bu/Cy-based regimen incorporating cytarabine (Ara-C) could be used according to institutional protocols. The regimen consisted of Ara-C at a total dose of 4-8 g/m², intravenous busulfan at a total dose of 9.6 mg/kg, and cyclophosphamide at a total dose of 3.6 g/m².
| Study group | Role | What they receive |
|---|---|---|
| MAC | Active comparator | Myeloablative conditioning is administered prior to allogeneic peripheral-blood hematopoietic stem-cell transplantation. Acceptable regimens include busulfan plus cyclophosphamide (Bu4/Cy2), busulfan plus fludarabine (Bu4/Flu). A modified Bu/Cy regimen is permitted for haploidentical transplantation. The specific regimen is selected according to institutional standard practice and study protocol. Receives: Procedure: MAC |
| RIC | Experimental | Reduced-intensity conditioning is administered prior to allogeneic peripheral-blood hematopoietic stem-cell transplantation. Acceptable regimens include fludarabine combined with busulfan (Flu/Bu2, Flu/Bu3), or fludarabine combined with melphalan (Flu/Mel). The specific regimen is selected according to institutional standard practice and study protocol. Receives: Procedure: RIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year relapse-free survival (RFS)
Relapse-free survival is defined as the time from randomization until disease relapse or death from any cause, whichever occurs first. Patients who are alive without relapse will be censored at the date of last follow-up.
Measured: 2 years after randomization
Secondary outcomes (4)
Overall survival (OS)
Overall survival is defined as the time from randomization to death from any cause. Patients alive at last follow-up will be censored.
Measured: 2 years after randomization
Non-relapse mortality (NRM)
Non-relapse mortality is defined as death without prior disease relapse. Cumulative incidence of non-relapse mortality will be estimated, with relapse treated as a competing risk.
Measured: 2 years after randomization
Cumulative incidence of relapse
Disease relapse defined as hematologic recurrence of FLT3-ITD mutated acute myeloid leukemia. Cumulative incidence of relapse will be estimated, with death without relapse treated as a competing risk.
Measured: 2 years after randomization
GVHD-free and relapse-free survival (GRFS)
GVHD-free, relapse-free survival is defined as time from randomization until grade III-IV acute GVHD, chronic GVHD requiring systemic immunosuppression, leukemia relapse, or death from any cause, whichever occurs first.
Measured: 2 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATIONStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, The First Affiliated Hospital of Zhengzhou University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog, Peking University People's Hospital, Tongji Hospital
- Responsible party
- Principal investigator, Yanmin Zhao, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904884
- Sponsor's protocol ID
- FLT3 - MAC vs RIC
- Acronym
- FLT3 - M vs R
- Status last verified
- Nov 2026
- First submitted
- 24 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers. No supporting information will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-label Randomized Trial Comparing Myeloablative vs Reduced-intensity Conditioning for Transplantation in FLT3-ITD-Mutated AML Guided by UHS-NGS MRD
- ClinicalTrials.gov ID
- NCT07904884
- Acronym / sponsor ID
- FLT3 - M vs R / FLT3 - MAC vs RIC
- Keywords
- FLT3-mutated AML, Myeloablative Conditioning, Reduced-intensity conditioning, Ultra-high-sensitivity next-generation sequencing（UHS-NGS）
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Ruijin Hospital, The First Affiliated Hospital of Zhengzhou University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog, Peking University People's Hospital, Tongji Hospital
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 29 Oct 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 is a multicenter, open-label, 1:1 randomized non-inferiority trial with stratification. The study will enroll patients aged 18-60 years with FLT3-ITD-mutated acute myeloid leukemia (AML) who are in first complete remission (CR1) and have no detectable FLT3-ITD measurable residual disease (MRD) by polymerase chain reaction-next-generation sequencing (PCR-NGS) before allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Eligible patients will be randomly assigned to receive either reduced-intensity conditioning (RIC) or myeloablative conditioning (MAC) before allo-HSCT. All patients will receive FLT3 inhibitor maintenance therapy after transplantation.
The primary objective is to determine whether RIC is non-inferior to MAC in terms of 2-year relapse-free survival (RFS), defined as the time from transplantation to relapse or death from any cause. Secondary objectives include comparisons of overall survival (OS), non-relapse mortality (NRM), cumulative incidence of relapse, and graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS) between the two conditioning groups.
Detailed description
FLT3 internal tandem duplication (FLT3-ITD) is an adverse prognostic factor in acute myeloid leukemia (AML). Although allogeneic hematopoietic stem cell transplantation (allo-HSCT) and post-transplant FLT3 inhibitor maintenance have improved outcomes, relapse remains a major cause of treatment failure. Conditioning intensity is an important determinant of both relapse and non-relapse mortality (NRM), and the optimal conditioning strategy for patients with FLT3-ITD-mutated AML remains uncertain.
Previous studies have shown that myeloablative conditioning (MAC) can reduce relapse compared with reduced-intensity conditioning (RIC), particularly in patients with detectable measurable residual disease (MRD) before transplantation. However, the benefits of MAC must be balanced against its greater treatment-related toxicity. These findings suggest that pre-transplant MRD status may help identify patients who can achieve adequate disease control with less intensive conditioning. In addition, post-transplant FLT3 inhibitor maintenance provides an additional strategy for reducing relapse risk in patients with FLT3-ITD-mutated AML.
A retrospective study conducted by the Chinese TROPHY collaborative group evaluated 219 patients with FLT3-ITD-mutated AML undergoing allo-HSCT, most of whom received post-transplant FLT3 inhibitor maintenance. Among patients with detectable pre-transplant FLT3-ITD MRD by an ultrasensitive next-generation sequencing assay, RIC was associated with higher relapse incidence and inferior relapse-free survival (RFS) and overall survival (OS) than MAC. In contrast, outcomes were comparable between conditioning groups among patients with undetectable pre-transplant molecular MRD. These findings support further prospective evaluation of an MRD-guided conditioning strategy.
This multicenter, open-label, randomized non-inferiority trial will compare RIC with MAC in patients with FLT3-ITD-mutated AML who are in first complete remission and have no detectable pre-transplant FLT3-ITD MRD by polymerase chain reaction-next-generation sequencing (PCR-NGS). Participants will be randomly assigned to one of the two conditioning strategies, and all participants will receive FLT3 inhibitor maintenance after allo-HSCT. The study is designed to determine whether RIC provides comparable relapse-free survival to MAC in this molecularly defined population while potentially reducing conditioning-related toxicity and NRM. The results may help establish a prospective evidence base for integrating pre-transplant molecular MRD status and post-transplant maintenance therapy into individualized conditioning-intensity selection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAC | Active comparator | Procedure: MACMyeloablative conditioning is administered prior to allogeneic peripheral-blood hematopoietic stem-cell transplantation. Acceptable regimens include busulfan plus cyclophosphamide (Bu4/Cy2), busulfan plus fludarabine (Bu4/Flu). A modified Bu/Cy regimen is permitted for haploidentical transplantation. The specific regimen is selected according to institutional standard practice and study protocol. |
| RIC | Experimental | Procedure: RICReduced-intensity conditioning is administered prior to allogeneic peripheral-blood hematopoietic stem-cell transplantation. Acceptable regimens include fludarabine combined with busulfan (Flu/Bu2, Flu/Bu3), or fludarabine combined with melphalan (Flu/Mel). The specific regimen is selected according to institutional standard practice and study protocol. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Age between 18 to 60 years, any gender
- Diagnosis of AML according to WHO criteria
- Presence of FLT3-ITD mutation at diagnosis
- In first complete remission
- Planned first allogeneic hematopoietic stem cell transplantation using peripheral blood stem cells
Key exclusion criteria (13 listed)
- Prior allogeneic hematopoietic stem cell transplantation
- Achieved complete remission (CR) only after more than two cycles of induction therapy, or met the criteria for primary refractory AML
- Clear evidence of disease progression, relapse, or a need to immediately initiate new anti-tumor therapy prior to randomization, which could significantly impact the assessment of study endpoints
- Active central nervous system (CNS) leukemia
- Uncontrolled severe infection prior to randomization, including but not limited to: Sepsis or septic shock; Active invasive fungal infection; Bacterial or viral infection requiring escalation of broad-spectrum anti-infective therapy where the clinical condition remains unstable; Other severe infections deemed by the investigator to make the patient unsuitable for 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 |
|---|---|---|
| RIC1. Flu/Bu2 or Flu/Bu3: The total dose of fludarabine is 120-180 mg/m², and the total intravenous dose of busulfan is 6.4-9.6 mg/kg. 2. Flu/Mel: The total dose of fludarabine is 120-180 mg/m², and the total dose of melphalan is 120-150 mg/m². For the purposes of this study, Flu/Bu3 is included in the RIC group as a protocol-specified reduced-toxicity conditioning regimen. | Procedure or surgery | RIC |
| MAC1. Bu4/Cy2: The total intravenous dose of busulfan is 12.8 mg/kg, and the total dose of cyclophosphamide is 120 mg/kg. 2. Bu4/Flu: The total intravenous dose of busulfan is 12.8 mg/kg, and the total dose of fludarabine is 120-180 mg/m². 3. Modified Bu/Cy regimen: For patients undergoing haploidentical transplantation, a modified Bu/Cy-based regimen incorporating cytarabine (Ara-C) could be used according to institutional protocols. The regimen consisted of Ara-C at a total dose of 4-8 g/m², intravenous busulfan at a total dose of 9.6 mg/kg, and cyclophosphamide at a total dose of 3.6 g/m². | Procedure or surgery | MAC |
Primary outcome
2-year relapse-free survival (RFS)
Time frame: 2 years after randomization
Relapse-free survival is defined as the time from randomization until disease relapse or death from any cause, whichever occurs first. Patients who are alive without relapse will be censored at the date of last follow-up.
4 secondary outcomes
Overall survival (OS)
Time frame: 2 years after randomization
Non-relapse mortality (NRM)
Time frame: 2 years after randomization
Cumulative incidence of relapse
Time frame: 2 years after randomization
GVHD-free and relapse-free survival (GRFS)
Time frame: 2 years after 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 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers. No supporting information will be made available.
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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.
YI YU, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIC and MAC in people with ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION and Acute Myeloid Leukemia, run by First Affiliated Hospital of Zhejiang University at 1 site 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 16 inclusion and 13 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Yanmin Zhao, PhD (+8615858199217, yanminzhao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year relapse-free survival (RFS) (time frame: 2 years after randomization). 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 4 Nov 2026.