Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia

Not Applicable

Recruiting

• Conditions: Stem Cell Transplant; Cord Blood; Leukemia

• Registration Number: NCT06155188
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

To determine if the novel regimen of PT/FLU+CY promotes cord blood engraftment in children's leukemia HSCT cohort

Detailed Description

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.

Study Timeline

• Study Start: 2019-09-29
• Status Verified: 2023-11
• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-23
• Last Update Submitted: 2023-11-23
• Study First Posted: 2023-12-04
• Last Update Posted: 2023-12-04
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• children acute leukemia

Exclusion Criteria

• MODS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
rate of UCB engraftment	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	3 years post-HSCT	determine the leukemia status post-HSCT
rate of overall survival	3 years post-HSCT	determine the overall survival status post-HSCT

Trial Locations

Locations (1)

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China