Disease-free SurvivalPhase 2NCT05436561
Reduced MBF Regimen for Patients >=55 Years With Myeloid Malignancies
A Phase 2 study testing MBF-RIC in people with Disease-free Survival, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML >=55 years. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Disease-free Survival
- What is being tested?
- MBF-RIC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2022to 30 Jun 2027
- Phase
- Phase 2
- 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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55-65
- patients with HLA-matched sibling donors, 9-10/10 matched unrelated donors or haplo-identical donors.
- patients with AML in remission, or MDS in any stage, or CMML in any stage
- inform consent provided
Who cannot join
- patients with abnormal liver (>3N), renal (1.5N) or cardiac function
- patients with active infection
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
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, Shanghai Municipality, 200025
Jiong HU, M.D.,, 86-21-64370045, hujiong@medmail.com.cn
Ling Wang, M.D.,, 86-21-64370045, cclingjar@163.com
- Recruiting
Shanghai No 6 Hospital
Shanghai
ChunKang Chang, +862164369181, changchunkang@sjtu.edu.cn
About this study
Official title: A Multiple-center Phase II Study to Evaluate the Clinical Outcome of Reduced Conditioning Regimen With Melphalan, Busulfan and Fludarabine for Patients >=55 Years With Myeloid Malignancies.
In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML >=55 years.
Read the detailed description
Conditioning regimen with double alkylating agents such as busulfan + melphalan or Busulfan + thiotepa have been shown to improve the transplantation outcome in terms of lower relapse rate in various myeloid malignancies. In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML >=55 years.
- Conditions
- Disease-free Survival
- Being tested
- MBF-RIC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBF-RICDrug
Also called MBF100
Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan
| Study group | Role | What they receive |
|---|---|---|
| MBF-RIC | Experimental | Patients with MBF-RIC as conditioning regimen Receives: Drug: MBF-RIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
survival without disease relapse or progression
Measured: 2 year
Secondary outcomes (4)
overall survival
survival
Measured: 2 year
GVHD and relapse free survival
survival without graft failure, without relapse, without III-IV aGVHD and without mod/sev cGVHD.
Measured: 2 year
Non-relapse mortality
Death without disease progression or relapse
Measured: 2 year
Relapse
disease progression or 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 posted29 Jun 2022
- Study start1 Jun 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease-free SurvivalStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 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
- Jiong Hu, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436561
- Sponsor's protocol ID
- MBF-RIC-2022
- Status last verified
- Mar 2026
- First submitted
- 23 Jun 2022
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-center Phase II Study to Evaluate the Clinical Outcome of Reduced Conditioning Regimen With Melphalan, Busulfan and Fludarabine for Patients >=55 Years With Myeloid Malignancies.
- ClinicalTrials.gov ID
- NCT05436561
- Acronym / sponsor ID
- MBF-RIC-2022
- Conditions
- Disease-free Survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Jun 2022 (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.
In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML >=55 years.
Detailed description
Conditioning regimen with double alkylating agents such as busulfan + melphalan or Busulfan + thiotepa have been shown to improve the transplantation outcome in terms of lower relapse rate in various myeloid malignancies. In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML >=55 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBF-RIC | Experimental | Drug: MBF-RICPatients with MBF-RIC as conditioning regimen |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 55-65
- patients with HLA-matched sibling donors, 9-10/10 matched unrelated donors or haplo-identical donors.
- patients with AML in remission, or MDS in any stage, or CMML in any stage
- inform consent provided
Key exclusion criteria (2 listed)
- patients with abnormal liver (>3N), renal (1.5N) or cardiac function
- patients with active infection
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 |
|---|---|---|
| MBF-RICAlso: MBF100Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan | Drug | MBF-RIC |
Primary outcome
disease-free survival
Time frame: 2 year
survival without disease relapse or progression
4 secondary outcomes
overall survival
Time frame: 2 year
GVHD and relapse free survival
Time frame: 2 year
Non-relapse mortality
Time frame: 2 year
Relapse
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 17 Mar 2026.
- 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.
Jiong Hu principal investigator
Shanghai Jiao Tong University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MBF-RIC in people with Disease-free Survival, run by Shanghai Jiao Tong University School of Medicine 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 4 inclusion and 2 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 17 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jieling Jiang (+8613311986505, jiangjieling66@hotmail.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 17 Mar 2026.