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

Shanghai Jiao Tong University

Status: Not yet enrolling

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

Treatments: Other: donor selection; Other: None-placebo; Other: non-intervention study

Study type: Observational

Funder types: Other

Identifiers

NCT06686173

SHSYXY-haplo-PBSCT-donor

Details and patient eligibility

About

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

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

2. ELN prognostic stratification high-risk group (see Appendix for criteria)

3. Non-remission (NR) AML: including primary refractory AML and NR patients after relapse.

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

5. Patients had to have a qualified haploidentical young male (≤30 years old) or female with a history of pregnancy;

6. 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;