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

NCT ID: NCT06155188

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-29

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Leukemia Stem Cell Transplant Cord Blood

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

applying of FLU+CY post-HSCT

Intervention Type PROCEDURE

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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* children acute leukemia

Exclusion Criteria

* MODS
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaoqin Feng, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, Nanfang Hospital, Southern Medical University

Locations

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Nanfang Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongsheng Ruan, MD

Role: CONTACT

Phone: 02062787966

Email: [email protected]

Xiaoqin Feng, MD

Role: CONTACT

Phone: +861382222

Email: [email protected]

Facility Contacts

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Yongsheng Ruan, MD

Role: primary

Other Identifiers

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NFEC-2022-229

Identifier Type: -

Identifier Source: org_study_id