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

Sponsor
Nanfang Hospital, Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06155188
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
86.1
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: applying of FLU+CY post-HSCT
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 29, 2019
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: PT/FLU+CY

The group consisted of fludarabine (40mg/m2, day-5 to day-3 and day+3, day+4), busulfan (100mg/m2, day-6 to day-3), haplo-PBSC (day0), cyclophosphamide (50mg/kg, day+3, day+4) , and UCB (day+6)

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).

Outcome Measures

Primary Outcome Measures

  1. 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

  2. rate of leukemia free survival [3 years post-HSCT]

    determine the leukemia status post-HSCT

  3. rate of overall survival [3 years post-HSCT]

    determine the overall survival status post-HSCT

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • children acute leukemia
Exclusion Criteria:
  • MODS

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanfang Hospital Guangzhou Guangdong China 510515

Sponsors and Collaborators

  • Nanfang Hospital, Southern Medical University

Investigators

  • Principal Investigator: Xiaoqin Feng, MD, Department of Pediatrics, Nanfang Hospital, Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nanfang Hospital, Southern Medical University
ClinicalTrials.gov Identifier:
NCT06155188
Other Study ID Numbers:
  • NFEC-2022-229
First Posted:
Dec 4, 2023
Last Update Posted:
Dec 4, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Leukemia

Study Results

No Results Posted as of Dec 4, 2023