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

NCT ID: NCT06686173

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 114 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2028-02-01

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

None-placebo

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

Intervention Type: OTHER

non-intervention study

This study is one kind of non intervention study

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xianmin Song, MD

professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

xia shao

Role: CONTACT

maizidemaidi@126.com

15216632623

Other Identifiers

SHSYXY-haplo-PBSCT-donor

Identifier Type: -

Identifier Source: org_study_id