A Prospective, Single-arm Clinical Study to Evaluate the Efficacy and Safety of Allogeneic Haematopoietic Stem Cell Transplantation With FLU-BU-MEL Conditioning for Myelodysplastic Syndromes

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To assess the safety and efficacy of FLU-BU-MEL as a conditioning regimen for allogeneic hematopoietic stem cell transplantation in patients with untreated MDS-EB or IPSS-R that is intermediate-risk (\>3.5 points), high-risk, or very high-risk. The investigators conducted this clinical trial.There will be three phases to this trial: screening, therapy, and follow-up. A) Screening phase: Qualified patients are screened for trial participation by a medical history, physical examination, laboratory testing, and disease evaluation after providing their informed consent. B) Treatment duration: patients receive allogeneic hematopoietic stem cell transplantation prepped with Flu-Bu-Mel in accordance with the protocol. C) Follow-up period: patients were checked on at the scheduled time to assess safety and efficacy. HSCT conditioning regiment: Flu 30 mg/m2/d d-6 days to d-2 9 (intravenously over two hours), : MEL 50 mg/m2/d intravenously, d-3 to d-2; BU 0.8 mg/kg/q6h d-6 to d-5 (intravenously, over 2 hours per drip). Fludarabine and melphalan do not require a dose adjustment based on body weight; however, if body mass index BMI\> 25, ideal body weight (IBW) should be calculated (as BMI=25), and then determine Busulfan dosage based on corrected body weight (AIBW25). AIBW25=IBW+25% x (actual body weight - IBW)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Diagnosis: Myelodysplastic Syndromes (IB1/IB2)

• Patients did not receive any anti-tumour therapy (including chemotherapy, immunotherapy (lenalidomide, etc.), targeted therapy, hormone therapy, etc.).

Locations
Other Locations
China
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Xiaoxia Hu
hu_xiaoxia@126.com
+86 021 64370045
Time Frame
Start Date: 2024-03-03
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 59
Treatments
Experimental: FBM group
undergoing FBM regiment
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov

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