Actively Recruiting

Phase 3
Age: 18Years - 55Years
All Genders
NCT06829472

Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomized Study of Different Dose of Melphalan

Led by Shanghai Jiao Tong University School of Medicine · Updated on 2025-02-17

120

Participants Needed

2

Research Sites

156 weeks

Total Duration

On this page

Sponsors

S

Shanghai Jiao Tong University School of Medicine

Lead Sponsor

S

Shanghai Clinical Research Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomized Study of Different Dose of Melphalan

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Informed consent provided
Not Eligible

You will not qualify if you...

  • Patients with active infection (bacterial, fungal, or viral)
  • Patients with abnormal liver, renal, or cardiac function

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Rui Jin Hospital

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

2

Zhaxin Hospital, Go Broad Health Care

Shanghai, Shanghai Municipality, China

Not Yet Recruiting

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Research Team

C

Chun Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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