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

The Effect of the Parous Female and Young Male Donor on the Outcomes of GVHD Prophylaxis Underwent the Combined Treatment of ATG and PTCy for Haplo-HSCT: a Prospective, Multi-center, Cohort Study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06686173

Acronym

Donor chose

Enrollment

114

Registered

2024-11-13

Start date

2025-02-01

Completion date

2028-02-01

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

OTHERNone-placebo

This is one kind descriptive study. The different donor groups made the cohorts different: the parous female donor and young male donor

OTHERnon-intervention study

This study is one kind of non intervention study

OTHERdonor selection

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

1\. Acute myeloid leukemia was diagnosed according to the 2016ELN criteria with any of the following: 1. ELN prognostic stratification high-risk group (see Appendix for criteria) 2. Non-remission (NR) AML: including primary refractory AML and NR patients after relapse. 2\. Patients must have a suitable hematopoietic stem-cell donor. 1. Patients had to have a qualified haploidentical young male (≤30 years old) or female with a history of pregnancy; 2. 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

1. Intermediate-low risk AML patients (ELN criteria); 2. Patients with extramedullary active lesions at the time of transplantation; 3. Haploidentical collateral donors; 4. Patients who refused allogeneic hematopoietic stem cell transplantation;

Design outcomes

Primary

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

Contacts

Primary Contactxia shao

maizidemaidi@126.com15216632623

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026