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

November 23, 2023 updated by: Nanfang Hospital, Southern Medical University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • children acute leukemia

Exclusion Criteria:

  • MODS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
initiate STR detection from day+15 thereafter weekly up to 1 year post-HSCT
rate of leukemia free survival
Time Frame: 3 years post-HSCT
determine the leukemia status post-HSCT
3 years post-HSCT
rate of overall survival
Time Frame: 3 years post-HSCT
determine the overall survival status post-HSCT
3 years post-HSCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 23, 2023

First Posted (Estimated)

December 4, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2022-229

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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