Sequential Transplantation of Haploidentical Stem Cell and Unrelated Cord Blood With Using ATG/PTCY Increases Survival of Relapsed/Refractory Hematologic Malignancies.
Hua Li, Xiaofan Li, Yiling Chen...
https://pubmed.ncbi.nlm.nih.gov/34804017Actively Recruiting
Phase Not Applicable
Age: 14Years - 60Years
All Genders
ID07588360
Haploidentical Combined With Cord Blood Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes: A Prospective, Multicenter Clinical Study
Led by Fujian Medical University Union Hospital · Updated on 2026-05-14
180
Participants Needed
4
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new combined hematopoietic stem cell transplantation approach for patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). This study focuses on a haploidentical-cord blood transplantation method, comparing different engraftment patterns to understand their impact on immune tolerance, complications, quality of life, and long-term survival. The goal is to provide new evidence to improve transplantation strategies for these serious blood disorders. The treatment involves a unique conditioning regimen including Fludarabine, Cytarabine, Busulfan, ATG, Melphalan, and Cyclophosphamide given over several days. Patients receive haploidentical stem cells on the day of transplantation (Day 0) and umbilical cord blood stem cells six days later (Day +6). Different dosing schedules are used depending on disease remission status before transplantation. This sequential infusion aims to enhance immune recovery and increase the chances of long-term cord blood engraftment. Participants will be monitored up to three years after transplantation to assess overall survival and other important outcomes like progression-free survival, disease-free survival, and graft-versus-host disease (GVHD) incidence. The study includes regular clinical assessments, immune tolerance evaluation, and quality of life measurements. This long-term follow-up will help clarify the benefits and risks of this combined transplantation approach and inform clinical decisions for AML and MDS patients.
CONDITIONS
Brief Title
Haplo-Cord HSCT for AML/MDS
Who Can Participate
Age: 14Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 14 and 60 years, with no gender restriction
- Intermediate- or high-risk AML in first complete remission (CR1)
- AML in second or subsequent complete remission (≥ CR2)
- Relapsed or refractory AML
- Low-risk AML with specific molecular or minimal residual disease criteria
- Intermediate-2 or high-risk MDS according to IPSS scoring
- Adequate general health status and ability to tolerate stem cell transplantation
- Signed informed consent and willingness to comply with follow-up and examinations
You will not qualify if you...
- Prior history of any hematopoietic stem cell transplantation
- History of ex vivo T-cell-depleted stem cell transplantation
- Expected survival less than 1 month after transplantation
- Severe organ dysfunction affecting liver, kidneys, heart, or lungs
- Active severe infection such as uncontrolled pneumonia or sepsis
- Severe hypersensitivity to study medications including cyclophosphamide or ATG
- Severe psychiatric disorders or cognitive impairment preventing compliance
- Pregnant or breastfeeding women
- Concurrent malignancy of another organ system
- Any other medical condition judged inappropriate for participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Conditioning Regimen
Duration - 5 to 7 days
Participants receive chemotherapy and immunosuppressive drugs to prepare their body for transplantation.
Daily visits for medication administration during conditioning
Transplantation
Duration - 1 week
Participants undergo infusion of haploidentical hematopoietic stem cells followed by umbilical cord blood stem cells to restore bone marrow function.
2 infusion visits: haploidentical stem cells on day 0 and cord blood stem cells on day 6
Post-Transplant Follow-up
Duration - Up to 3 years
Participants are monitored for engraftment, graft-versus-host disease, immune recovery, relapse, and overall health.
Regular follow-up visits over 3 years to assess recovery and outcomes
Trial Site Locations
Total: 4 locations
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
2
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
3
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
4
Chinese PLA General Hospital
Beijing, China
Not Yet Recruiting
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Research Team
N
Nainong Li, MD
L
Lihua Wu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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