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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-55
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

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

Disqualifiers

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;

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • None-placebo

    Other intervention

    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 intervention

    This study is one kind of non intervention study

  • donor selection

    Other intervention

    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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

RFS

1-year RFS after transplantation

Time frame
one year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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