An interventional study of RIC and MAC in ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION and Acute Myeloid Leukemia, sponsored by First Affiliated Hospital of Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by First Affiliated Hospital of Zhejiang University · Not applicable, Interventional, and Treatment
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.
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.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's planned enrollment of 310 is above the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 263 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: MAC
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.
Procedure: RIC
1. 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.
1. 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.
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.
Time frame: 2 years after randomization
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years after randomization
Plan to share: No — Individual participant data (IPD) will not be shared with other researchers. No supporting information will be made available.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2028, 23 months later.
Of 132 non-industry interventional studies with no phase under Leukemia, Myeloid, Acute, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 128. This study's planned 23 months is below that.
Counting every sponsor, half of 139 studies reached it within 47 months; a quarter within 25 and three quarters within 123.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Zhejiang University →