Actively Recruiting
A Novel Post-transplant Regimen of PT/FLU+CY for Promoting Unrelated Cord Blood Engraftment in Haploidentical-cord Transplantation in Childhood Leukemia
Led by Nanfang Hospital, Southern Medical University · Updated on 2023-12-04
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new post-transplant treatment regimen combining post-transplant cyclophosphamide, fludarabine, and cyclophosphamide (PT/FLU+CY) to see if it helps unrelated cord blood engraft better in children undergoing haploidentical-cord stem cell transplantation for leukemia. This study focuses on childhood leukemia patients receiving this novel approach to improve the unpredictability of graft engraftment in this transplant setting. The treatment involves a conditioning regimen with fludarabine given from day -5 to day -3 and again on days +3 and +4, busulfan from day -6 to day -3, infusion of haploidentical peripheral blood stem cells on day 0, cyclophosphamide on days +3 and +4, and unrelated cord blood infusion on day +6. This regimen is being studied as a single-arm, multi-center trial to assess its effects on promoting cord blood engraftment. Participants will be monitored starting from day +15 post-transplant with weekly STR detection for up to one year to measure cord blood engraftment. Researchers will also follow leukemia-free survival and overall survival rates for three years after transplantation. The study involves regular evaluations to assess the effects of the treatment and monitor patient outcomes during and after the transplant process.
CONDITIONS
Brief Title
Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children with acute leukemia
- Age between 1 month and 18 years
You will not qualify if you...
- Presence of multiple organ dysfunction syndrome (MODS)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks starting from 6 days before transplant to 6 days after transplant
Participants receive a post-transplant regimen including fludarabine, busulfan, haploidentical peripheral blood stem cell transplant, cyclophosphamide, and unrelated cord blood infusion.
Daily visits during conditioning and transplant period
Duration - Up to 3 years post-transplant
Participants are monitored for engraftment, leukemia-free survival, and overall survival for up to 3 years post-transplant.
Weekly visits from day 15 to 1 year post-transplant and periodic visits up to 3 years
Trial Site Locations
Total: 1 location
1
Nanfang Hospital
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
Y
Yongsheng Ruan, MD
X
Xiaoqin Feng, 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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