MedTrace Logo

Evaluate the Efficacy and Safety of Allogeneic Haematopoietic Stem Cell Transplantation With FBM Conditioning for MDS

NCT06247917 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2024-03-21

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Fludarabine, Busulfan and Melphalan

Use Fludarabine, Busulfan and Melphalan as myeloablative conditioning regimen for untreated MDS-EB patients.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Luxiang Wang · Ruijin Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-03
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06247917 on ClinicalTrials.gov