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Not yet recruiting NCT06686173

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: None-placebo, non-intervention study, donor selection.
Who it may be relevant to
Registry conditions: High-Risk Acute Myeloid Leukemia, Relapse And/or Refractory AML. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Other None-placebo
    This is one kind descriptive study. The different donor groups made the cohorts different: the parous female donor and young male donor
  • Other non-intervention study
    This study is one kind of non intervention study
  • Other donor 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

Primary outcome measures

  • RFS [Time frame: one year]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06686173 · SHSYXY-haplo-PBSCT-donor

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗