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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06155188
Enrollment
60
Registered
2023-12-04
Start date
2019-09-29
Completion date
2026-12-31
Last updated
2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cord Blood, Leukemia, Stem Cell Transplant

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.

Interventions

PROCEDUREapplying 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).

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

* children acute leukemia

Exclusion criteria

* MODS

Design outcomes

Primary

MeasureTime frameDescription
rate of UCB engraftmentinitiate STR detection from day+15 thereafter weekly up to 1 year post-HSCTevaluate the regimen if it promotes UCB engraftment
rate of leukemia free survival3 years post-HSCTdetermine the leukemia status post-HSCT
rate of overall survival3 years post-HSCTdetermine the overall survival status post-HSCT

Countries

China

Contacts

Primary ContactYongsheng Ruan, MD
vimmer@smu.edu.cn02062787966
Backup ContactXiaoqin Feng, MD
fxq126126@126.com+861382222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026