NCT06155188

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable leukemia

Timeline
7mo left

Started Sep 2019

Longer than P75 for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Sep 2019Dec 2026

Study Start

First participant enrolled

September 29, 2019

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

7.2 years

First QC Date

November 13, 2023

Last Update Submit

November 23, 2023

Conditions

LeukemiaStem Cell TransplantCord Blood

Outcome Measures

Primary Outcomes (3)

  • 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

  • rate of leukemia free survival

    determine the leukemia status post-HSCT

    3 years post-HSCT

  • rate of overall survival

    determine the overall survival status post-HSCT

    3 years post-HSCT

Study Arms (1)

PT/FLU+CY

EXPERIMENTAL

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

Interventions

applying of FLU+CY post-HSCTPROCEDURE

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).

PT/FLU+CY

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children acute leukemia

You may not qualify if:

  • MODS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Xiaoqin Feng, MD

    Department of Pediatrics, Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongsheng Ruan, MD

CONTACT

02062787966vimmer@smu.edu.cn

Xiaoqin Feng, MD

CONTACT

+861382222fxq126126@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2023

First Posted

December 4, 2023

Study Start

September 29, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 4, 2023

Record last verified: 2023-11

Locations

CN(1)