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

Not yet recruiting

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

• Registration Number: NCT06686173
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-05
• Last Update Posted: 2025-01-07
• Study Start: 2025-02-01
• Primary Completion: 2027-02-01
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 114

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RFS	one year	1-year RFS after transplantation