Effect of Donor Chose on the Outcomes of GVHD Prophylaxis... | NCT06686173

Studies
Effect of Donor Chose on the Outcomes of GVHD Prophylaxis Underwent the Combined Treatment of ATG/PTCy for Haplo-HSCT

NCT06686173

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Status

Not yet recruiting

Last Update Posted

Jan 7, 2025Actual

Enrollment

114Estimated

Phase

Not provided

Conditions

High-Risk Acute Myeloid Leukemia
Relapse And/or Refractory AML

Interventions

None-placebo
non-intervention study
donor selection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2025Estimated

Primary Completion Date

Feb 1, 2027Estimated

Completion Date

Feb 1, 2028Estimated

First Submitted Date

Nov 11, 2024

First Submission Date that Met QC Criteria

Nov 11, 2024

First Posted Date

Nov 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2025

Last Update Posted Date

Jan 7, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xianmin Song, MD, professor of medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a prospective, multicenter, cohort study. The high-risk, relapse and refractory AML patients were enrolled in this study. And the goal of this study is to study the effect of the parous female donor and young male donor on the outcomes of graft-versus-host disease (GVHD) prophylaxis underwent the combination of ATG and PTCy for haploidentical peripheral blood stem cell transplantation

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

114Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
None-placebo	Other	This is one kind descriptive study. The different donor groups made the cohorts different: the parous female donor and young male donor
non-intervention study	Other	This study is one kind of non intervention study
donor selection	Other	the intervention of this study was the different donor groups: the parous female donor and young male donor. All the patients involved in this study were treated by the combination of ATG and PTCy

Measure	Description	Time Frame
RFS	1-year RFS after transplantation	one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Acute myeloid leukemia was diagnosed according to the 2016ELN criteria with any of the following:

ELN prognostic stratification high-risk group (see Appendix for criteria)
Non-remission (NR) AML: including primary refractory AML and NR patients after relapse.

2. Patients must have a suitable hematopoietic stem-cell donor.

Patients had to have a qualified haploidentical young male (≤30 years old) or female with a history of pregnancy;
Related donors had to be related donors matched 5/10-7/10 for HLA-A, -B, -C, -DQB1 and -DRB1 3. All the enrolled patients received a unified GVHD prevention regimen based on ATG and PTCy

Exclusion Criteria:

Intermediate-low risk AML patients (ELN criteria);
Patients with extramedullary active lesions at the time of transplantation;
Haploidentical collateral donors;
Patients who refused allogeneic hematopoietic stem cell transplantation;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

The high-risk, relapse and refractory AML patients were enrolled in this study

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
xia shao	Contact	15216632623		maizidemaidi@126.com

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D020858	Tissue and Organ Harvesting
D014180	Transplantation
D013514	Surgical Procedures, Operative
D009927	Tissue and Organ Procurement
D006296	Health Services
D005159	Health Care Facilities Workforce and Services