Posttransplant cyclophosphamide vs antithymocyte globulin in HLA-mismatched unrelated donor transplantation.
Giorgia Battipaglia, Myriam Labopin, Nicolaus Kröger...
https://pubmed.ncbi.nlm.nih.gov/31270102/Actively Recruiting
Led by Fujian Medical University Union Hospital · Updated on 2026-06-10
82
Participants Needed
4
Research Sites
36 weeks
Total Duration
Researchers are evaluating the clinical effectiveness of haploidentical-cord blood hematopoietic stem cell transplantation in patients with acute myeloid leukemia AML and high-risk myelodysplastic syndromes MDS. The study focuses on comparing different engraftment patternshaploidentical engraftment versus cord blood engraftmentand their effects on outcomes such as immune tolerance, quality of life, early complications, and long-term prognosis. This research aims to provide new evidence for clinical practice by exploring the advantages and effectiveness of this combined transplantation relative to conventional approaches. Treatment involves a novel sequential infusion strategy where haploidentical stem cells are given on Day 0, followed by umbilical cord blood stem cells on Day 6. Patients receive a unique myeloablative conditioning regimen including drugs such as Fludarabine, Cytarabine, Busulfan, ATG, Melphalan, and Cyclophosphamide, with dosing adjusted based on remission status. This approach seeks to balance immune modulation and myeloablation to support long-term cord blood engraftment and reduce complications like graft-versus-host disease. Participants will be closely monitored for outcomes including overall survival measured three years after transplantation. Assessments include immune recovery, relapse rates, graft-versus-host disease incidence, and quality of life evaluations. The study involves follow-up visits and examinations to evaluate hematopoietic recovery, immune tolerance, and long-term prognosis. The total duration includes treatment and extended monitoring to gather comprehensive data on safety and effectiveness.
CONDITIONS
Haplo-Cord HSCT for AML/MDS
N
Nainong Li, MD
L
Lihua Wu, MD
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Fujian Medical University Union Hospital
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are evaluated to confirm they meet eligibility criteria for the trial.
1 to 2 visits for screening assessments
Duration - Approximately 2 weeks
Participants receive a conditioning regimen followed by haploidentical stem cell infusion on Day 0 and cord blood stem cell infusion on Day 6.
Multiple visits during conditioning and transplantation period
Duration - Up to 3 years after transplantation
Participants undergo monitoring for immune recovery, graft-versus-host disease, relapse, and survival outcomes over several years.
Regular follow-up visits for assessments and laboratory tests
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Lead Sponsor