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Reduced MBF Regimen for Patients >=55 Years With Myeloid Malignancies

ConditionDisease-free Survival
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-65
SponsorShanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

patients with abnormal liver (>3N), renal (1.5N) or cardiac function

patients with active infection

Trial design

Design model

Single group

Treatments tested in this trial

  • MBF-RIC

    Drug

    Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan

Treatment groups

61 Participants
are divided into 1 treatment group
Group A: MBF-RICExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

disease-free survival

survival without disease relapse or progression

Time frame
2 year

Secondary outcomes

1

overall survival

survival

Time frame
2 year
2

GVHD and relapse free survival

survival without graft failure, without relapse, without III-IV aGVHD and without mod/sev cGVHD.

Time frame
2 year
3

Non-relapse mortality

Death without disease progression or relapse

Time frame
2 year
4

Relapse

disease progression or relapse

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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