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

NCT06686173 | Not Yet Recruiting

• 1 other identifier: SHSYXY-haplo-PBSCT-donor
• Study Type: observational
• Target: 114
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• RFS

  1-year RFS after transplantation

  one year

Interventions

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The high-risk, relapse and refractory AML patients were enrolled in this study

You may qualify if:

• \. 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Biospecimen

Retention: SAMPLES WITH DNA

the bone marrow and peripheral Blood

MeSH Terms

Interventions

Donor Selection

Intervention Hierarchy (Ancestors)

Tissue and Organ Harvesting; Transplantation; Surgical Procedures, Operative; Tissue and Organ Procurement; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

xia shao

CONTACT

15216632623; maizidemaidi@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of medicine

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 7, 2025

Record last verified: 2025-01