Acute Myeloid LeukemiaPhase 3NCT05991908
Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies
A Phase 3 study testing Fludarabine, busulfan and melphalan and Fludarabine and Busulfan in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Shanghai Jiao Tong University School of Medicine at 9 sites in China.
Trial summary
Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15~20%. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- Fludarabine, busulfan and melphalan and Fludarabine and Busulfan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 9 sitesChina
- Study dates
- 19 Oct 2023to 30 Jun 2026
- 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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- acute myeloid leukemia (acute promyelocytic leukemia excluded) in 1st complete remission
- myelodysplasia syndrome with bone marrow blast >5% and remaining less than 20% at transplantation
- patients with HLA matched sibling donor, 9-10 matched unrelated donor or haplo-identical related donors
- inform consent provided
Who cannot join
- AML patients with active CNS or extramedullary diseases
- patients with active viral, bacterial or fungal infection
- patients with hepatitis B virus >1X103 copy/ml
- patients with abnormal liver function, renal function, respiratory or cardiac dysfunction
- patients with uncontrolled mental disorders
- patients with HIV
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Xiaofan Li, 8618250490368, morningshiplee@sina.cn
- Recruiting
920th Hospital PLA
Kunming, 650000
Xiaoping Li, 8618523894353, xiaopinllli@163.com
- Recruiting
First Affiliated Hospital of Nanjin Medical Unviersity
Nanjin, Jiangsu, 210029
Kourong Miao, 8613813828314, kourongmiao@163.com
- Recruiting
923th Hospital PLA
Nanning, Guangxi, 530021
Xiaolin Yin, 8613321717899, 280662268@qq.com
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Jiong HU, 8613764313546, hj10709@rjh.com.cn
- Recruiting
Shanghai No10 Hospital
Shanghai, Shanghai Municipality
Houcai Wang, 8618019498303, houcaiwang@163.com
- Recruiting
Shanghai No 6 Hospital
Shanghai
ChunKang Chang, 8618930177640, changchunkang0710@aliyun.com
- Recruiting
First Affiliatied Hospital of Soochow University
Suzhou, Jiangsu, 215006
Xiaojin Wu, 861305749353, wuxiaojin@suda.edu.cn
- Recruiting
Zhongshan Hospital, Xianmen University
Xiamen, Fujian, 361004
quanyi Lu, 8613300959425, luquanyi@xmu.edu.cn
About this study
Official title: Multiple-center Randomized Study to Compare Fludarabine and Busulfan Versus Fludarabine, Busulfan and Melphalan in Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplasia Syndrome (MDS)
Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15~20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (<10%). This multiple-center randomize study is aim to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu4 vs. FLu-Bu-Mel.
Read the detailed description
Fludarabine and busulfan was considered as myeloablative but reduced toxicity regimen and became as the mainstay of conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The disease relapse remained as major cause of treatment failure. In general, the cumulated incidence of relapse (CIR) is about 15~20% dependent on the risk of patients undergoing allogeneic stem cell transplantation (allo-HSCT). Conditioning regimen with dual alkylating agents such as fludarabine, busulfan and thiotepa (TBF) showed decreased risk of relapse in myeloid malignancies. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan could achieve a low incidence of relapse (2 year CIR <10%). In this multiple-center randomize study, the aim is to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu vs. Flu-Bu-Mel.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- Fludarabine, busulfan and melphalan, Fludarabine and Busulfan
- Keywords
- conditioning regimen, melphalan, busulfan, fludarabine
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludarabine, busulfan and melphalanDrug
FLudarabine 150mg/m2 + Busulfan 6.4mg.kg + Mel 140mg/m2
Fludarabine and BusulfanDrug
FLudarabine 150mg/m2 + Busulfan 12.8mg.kg
| Study group | Role | What they receive |
|---|---|---|
| Flu-Bu2-Mel140 | Experimental | Patients receive fludarabine, busulfan and melphalan as conditioning regimen Receives: Drug: Fludarabine, busulfan and melphalan |
| Flu-Bu4 | Active comparator | Patients receive fludarabine and busulfan as conditioning regimen Receives: Drug: Fludarabine and Busulfan |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
event defined as relapse and death of any causes
Measured: 2 year
Secondary outcomes (4)
overall survival
event defined as death of any causes
Measured: 2 year
incidence of relapse
event defined as disease relapse (bone marrow or extra medullary)
Measured: 2 year
non relapse mortality
event defined as death without disease relapse
Measured: day 100
non relapse mortality
event defined as death without disease relapse
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 posted15 Aug 2023
- Study start19 Oct 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- study group with fludarabine, busulfan and melphalan regimen versus control group with fludarabine and busulfan
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiong HU, Shanghai Jiao Tong University School of Medicine
- Investigators
- Chun Wang, Principal investigator, Go Broad Health Center, Zhaxin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991908
- Sponsor's protocol ID
- MBF-FB4
- Status last verified
- Feb 2025
- First submitted
- 8 Aug 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-center Randomized Study to Compare Fludarabine and Busulfan Versus Fludarabine, Busulfan and Melphalan in Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplasia Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT05991908
- Acronym / sponsor ID
- MBF-FB4
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Keywords
- conditioning regimen, melphalan, busulfan, fludarabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Aug 2023 (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.
Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15~20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (<10%). This multiple-center randomize study is aim to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu4 vs. FLu-Bu-Mel.
Detailed description
Fludarabine and busulfan was considered as myeloablative but reduced toxicity regimen and became as the mainstay of conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The disease relapse remained as major cause of treatment failure. In general, the cumulated incidence of relapse (CIR) is about 15~20% dependent on the risk of patients undergoing allogeneic stem cell transplantation (allo-HSCT). Conditioning regimen with dual alkylating agents such as fludarabine, busulfan and thiotepa (TBF) showed decreased risk of relapse in myeloid malignancies. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan could achieve a low incidence of relapse (2 year CIR <10%). In this multiple-center randomize study, the aim is to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu vs. Flu-Bu-Mel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- study group with fludarabine, busulfan and melphalan regimen versus control group with fludarabine and busulfan
| Arm | Type | Receives |
|---|---|---|
| Flu-Bu2-Mel140 | Experimental | Drug: Fludarabine, busulfan and melphalanPatients receive fludarabine, busulfan and melphalan as conditioning regimen |
| Flu-Bu4 | Active comparator | Drug: Fludarabine and BusulfanPatients receive fludarabine and busulfan as conditioning regimen |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- acute myeloid leukemia (acute promyelocytic leukemia excluded) in 1st complete remission
- myelodysplasia syndrome with bone marrow blast >5% and remaining less than 20% at transplantation
- patients with HLA matched sibling donor, 9-10 matched unrelated donor or haplo-identical related donors
- inform consent provided
Key exclusion criteria (6 listed)
- AML patients with active CNS or extramedullary diseases
- patients with active viral, bacterial or fungal infection
- patients with hepatitis B virus >1X103 copy/ml
- patients with abnormal liver function, renal function, respiratory or cardiac dysfunction
- patients with uncontrolled mental disorders
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 |
|---|---|---|
| Fludarabine, busulfan and melphalanFLudarabine 150mg/m2 + Busulfan 6.4mg.kg + Mel 140mg/m2 | Drug | Flu-Bu2-Mel140 |
| Fludarabine and BusulfanFLudarabine 150mg/m2 + Busulfan 12.8mg.kg | Drug | Flu-Bu4 |
Primary outcome
disease-free survival
Time frame: 2 year
event defined as relapse and death of any causes
4 secondary outcomes
overall survival
Time frame: 2 year
incidence of relapse
Time frame: 2 year
non relapse mortality
Time frame: day 100
non relapse mortality
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 18 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Chun Wang principal investigator
Go Broad Health Center, Zhaxin Hospital
9 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 Fludarabine, busulfan and melphalan and Fludarabine and Busulfan in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Shanghai Jiao Tong University School of Medicine at 9 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 4 inclusion and 6 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 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 chun Wang (13386259777, wangchunsh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (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 18 Feb 2025.