NCT05436561 Reduced MBF Regimen for Patients >=55 Years With Myeloid Malignancies
| NCT ID | NCT05436561 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | Disease-free Survival |
| Study Type | INTERVENTIONAL |
| Enrollment | 61 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 61 participants in total. It began in 2022-06-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * patients with abnormal liver (\>3N), renal (1.5N) or cardiac function * patients with active infection
Contact & Investigator
Jiong Hu
PRINCIPAL INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Frequently Asked Questions
Who can join the NCT05436561 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 65 Years, studying Disease-free Survival. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05436561 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05436561 currently recruiting?
Yes, NCT05436561 is actively recruiting participants. Contact the research team at jiangjieling66@hotmail.com for enrollment information.
Where is the NCT05436561 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT05436561 clinical trial?
NCT05436561 is sponsored by Shanghai Jiao Tong University School of Medicine. The principal investigator is Jiong Hu at Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 61 participants.