Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Location status: Recruiting
Recruiting
NCT Number: NCT06155188
Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia
To determine if the novel regimen of PT/FLU+CY promotes cord blood engraftment in children's leukemia HSCT cohort
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
1 month–18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
PTCy is a well-established haploidentical transplant regimen strategy. Moreover, unrelated cord blood (UCB) plays a critical role in the effects of GVL. However, the engraftment of grafts is unpredictable in the setting of a haplo-cord subsequent transplant. Therefore, applying a novel post-transplant regimen of PT/CY+FLU may selectively promote UCB engraftment in the setting of haplo-cord transplant.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- children acute leukemia
Exclusion criteria
- MODS
Treatment and study plan
applying of FLU+CY post-HSCT
ProcedureThe conditioning regimen (PT-Cy/Flu group) consisted of fludarabine (40mg/m2, d-5 to d-3 and d+3, d+4), busulfan (100mg/m2, d-6 to d-3), haplo-PBSC (d0), PTCy (50mg/kg, d+3, d+4) and UCB (d+6).
Primary outcomes
-
rate of UCB engraftment
Time frame: initiate STR detection from day+15 thereafter weekly up to 1 year post-HSCT
evaluate the regimen if it promotes UCB engraftment
-
rate of leukemia free survival
Time frame: 3 years post-HSCT
determine the leukemia status post-HSCT
-
rate of overall survival
Time frame: 3 years post-HSCT
determine the overall survival status post-HSCT
Study contacts
Contact information is provided by the study sponsor or research team.
Xiaoqin Feng, MD
CONTACT
Yongsheng Ruan, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Nanfang Hospital, Southern Medical University
Other
Registry information
Official study title
A Novel Post-transplant Regimen of PT/FLU+CY for Selectively Promoting Unrelated Cord Blood Engraftment in Haploidentical-cord Transplantation in Childhood Leukemia: a Single-arm, Multi-center Trial
Important dates
- Study start
- 2019
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Dec 4, 2023
- Registry last updated
- Dec 4, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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