ToxicitiesPhase 3NCT06829472
Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomized Study of Different Dose of Melphalan
A Phase 3 study testing melphalan in people with Toxicities and Survivorship, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
Conditioning regimen with melphalan-busulfan and fludarabine (MBF) achieved low relapse rate in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In our previous retrospective study, we demonstrated that melphalan dose at 100 or 140mg/m2 had similar incidence of relapse but it might had… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Toxicities, Survivorship
- What is being tested?
- melphalan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2023to 1 Dec 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with AML in first remission
- Patients with MDS with bone marrow blast >5% but remain less than 20% before transplantation
- Donor available: HLA matched sibling donor, 9~10/10 matched unrelated donor or haplo-identical donor
- Inform consent provided
Who cannot join
- Patients with active infection (bacteria, fungal or viral)
- Patients with abnormal liver, renal and cardiac function
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
Rui Jin Hospital
Shanghai, Shanghai Municipality, 200025
jiong HU, 86-13764313546, hj10709@rjh.com.cn
- Not yet recruiting
Zhaxin Hospital, Go Broad Health Care
Shanghai, Shanghai Municipality
Chun Wang, 86-13386259777, wangchunsh@medmail.com.cn
About this study
Official title: Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomize Study Comparing 100mg/m2 to 140mg/m2 Melphalan for Adult Patients With Acute Myeloid Leukemia or Myelodysplasia Syndrome.
Conditioning regimen with melphalan-busulfan and fludarabine (MBF) achieved low relapse rate in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In our previous retrospective study, we demonstrated that melphalan dose at 100 or 140mg/m2 had similar incidence of relapse but it might had lower toxicities. In this prospective randomize study, we aim to compare the transplantation outcome in adult patients with AML/MDS receiving either MBF with 100 or 140 mg/m2 melphalan.
Read the detailed description
Intensity of conditioning regimen plays a important role in allogeneic stem cell transplantation (allo-HSCT) for patents with AML and MDS. IN our previous prospective study, we demonstrated that condoning regimen of dual alkylating agents with melphalan-busulfan and fludarabine (MBF) achieved a very low relapse rate (~6%) in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In that study, adult patients received melphalan 140mg/m2 while patients >=60 or with high transplantation risk in terms of HCT-CI received reduced dose of melphalan (100mg/m2). Overall, it was shown that 100 or 140mg/m2 melphalan had similar incidence of relapse while the 100mg/m2 melphalan presented lower incidence of toxicities.In this prospective randomize study, we aim to compare the transplantation toxicities and outcomes in young adults (18~55) with AML/MDS receiving either 100 or 140 mg/m2 melphalan as conditioning regimen.
- Conditions
- Toxicities, Survivorship
- Being tested
- melphalan
- Keywords
- melphalan, AML, MDS, allogeneic stem cell transplantation
- 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.
melphalanDrug
Also called MBF
conditioning regimen with melphalan, busulfan and fludarabine
| Study group | Role | What they receive |
|---|---|---|
| MBF100 | Experimental | Patients receive condoning regimen with melphalan (100mg/m2) with busulfan and fludarabine. Receives: Drug: melphalan |
| MBF140 | Active comparator | Patients receive condoning regimen with melphalan (140mg/m2) with busulfan and fludarabine. Receives: Drug: melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities
Toxicities with grade III or over
Measured: up to 100 days
Secondary outcomes (5)
Relapse
Documentation of bone marrow blasts >5% or extra medullary disease
Measured: 2 years
Non-relapse mortality
Death without documentation of AML and MDS disease
Measured: 100 days
Non-relapse mortality
Death without documentation of AML and MDS disease
Measured: 2 years
disease-free survival
event defined as documentation of AML and MDS relapse or death of any causes
Measured: 2 years
overall survival
event defined as death of any causes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Dec 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToxicitiesStudies 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
- Treatment
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Clinical Research Center
- Responsible party
- Principal investigator, Jiong HU, Shanghai Jiao Tong University School of Medicine
- Investigators
- chun Wang, Study director, Go Broad Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829472
- Sponsor's protocol ID
- MBF-RJH-2023
- Status last verified
- Feb 2025
- First submitted
- 12 Aug 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomize Study Comparing 100mg/m2 to 140mg/m2 Melphalan for Adult Patients With Acute Myeloid Leukemia or Myelodysplasia Syndrome.
- ClinicalTrials.gov ID
- NCT06829472
- Acronym / sponsor ID
- MBF-RJH-2023
- Conditions
- Toxicities, Survivorship
- Keywords
- melphalan, AML, MDS, allogeneic stem cell transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Clinical Research Center
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Feb 2025 (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.
Conditioning regimen with melphalan-busulfan and fludarabine (MBF) achieved low relapse rate in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In our previous retrospective study, we demonstrated that melphalan dose at 100 or 140mg/m2 had similar incidence of relapse but it might had lower toxicities. In this prospective randomize study, we aim to compare the transplantation outcome in adult patients with AML/MDS receiving either MBF with 100 or 140 mg/m2 melphalan.
Detailed description
Intensity of conditioning regimen plays a important role in allogeneic stem cell transplantation (allo-HSCT) for patents with AML and MDS. IN our previous prospective study, we demonstrated that condoning regimen of dual alkylating agents with melphalan-busulfan and fludarabine (MBF) achieved a very low relapse rate (~6%) in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In that study, adult patients received melphalan 140mg/m2 while patients >=60 or with high transplantation risk in terms of HCT-CI received reduced dose of melphalan (100mg/m2). Overall, it was shown that 100 or 140mg/m2 melphalan had similar incidence of relapse while the 100mg/m2 melphalan presented lower incidence of toxicities.In this prospective randomize study, we aim to compare the transplantation toxicities and outcomes in young adults (18~55) with AML/MDS receiving either 100 or 140 mg/m2 melphalan as conditioning regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment
| Arm | Type | Receives |
|---|---|---|
| MBF100 | Experimental | Drug: melphalanPatients receive condoning regimen with melphalan (100mg/m2) with busulfan and fludarabine. |
| MBF140 | Active comparator | Drug: melphalanPatients receive condoning regimen with melphalan (140mg/m2) with busulfan and fludarabine. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with AML in first remission
- Patients with MDS with bone marrow blast >5% but remain less than 20% before transplantation
- Donor available: HLA matched sibling donor, 9~10/10 matched unrelated donor or haplo-identical donor
- Inform consent provided
Key exclusion criteria (2 listed)
- Patients with active infection (bacteria, fungal or viral)
- Patients with abnormal liver, renal and cardiac function
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 |
|---|---|---|
| melphalanAlso: MBFconditioning regimen with melphalan, busulfan and fludarabine | Drug | MBF100, MBF140 |
Primary outcome
Toxicities
Time frame: up to 100 days
Toxicities with grade III or over
5 secondary outcomes
Relapse
Time frame: 2 years
Non-relapse mortality
Time frame: 100 days
Non-relapse mortality
Time frame: 2 years
disease-free survival
Time frame: 2 years
overall survival
Time frame: 2 years
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 Feb 2025.
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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 study director
Go Broad Health Care
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 melphalan in people with Toxicities and Survivorship, 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 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 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 Chun Wang (86-13386259777, Wangchunsh@mefmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicities (time frame: up to 100 days). 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 Feb 2025.