Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06686173

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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;

Treatment and study plan

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

Primary outcomes

  1. RFS

    Time frame: one year

    1-year RFS after transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

xia shao

CONTACT

[email protected]

15216632623

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Acronym: Donor chose

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 13, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.