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NCT06686173Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 7 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
114 (estimated)
First submitted
11 Nov 2024
Start date
1 Feb 2025
Primary completion date
1 Feb 2027
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
NCT number
NCT06686173

What you commit to

  • Study type: Observational
  • Planned participants: 114
  • From 1 Feb 2025 to the primary completion date, 1 Feb 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with extramedullary active lesions at the time of transplantation;
  • Patients who refused allogeneic hematopoietic stem cell transplantation;

Other

  • Intermediate-low risk AML patients (ELN criteria);
  • Haploidentical collateral donors;

Who the study is looking for

  • 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

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.