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NCT06155188 Clinical Trial

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

Leukemia Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06155188
Other study ID # NFEC-2022-229
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 29, 2019
Est. completion date December 2026

Study information
Verified date November 2023
Source Nanfang Hospital, Southern Medical University
Contact Yongsheng Ruan, MD
Phone 02062787966
Email vimmer@smu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria: - children acute leukemia Exclusion Criteria: - MODS

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• applying of FLU+CY post-HSCT
The 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).

Locations
Country Name City State
China Nanfang Hospital Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary rate of UCB engraftment evaluate the regimen if it promotes UCB engraftment initiate STR detection from day+15 thereafter weekly up to 1 year post-HSCT
Primary rate of leukemia free survival determine the leukemia status post-HSCT 3 years post-HSCT
Primary rate of overall survival determine the overall survival status post-HSCT 3 years post-HSCT
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