Combination of ATG-based Conditioning Regimen and PTCy for GVHD Prevention in Allo-HSCT After PD-1 Blockade

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing 302 Hospital

About this trial

The aim of this study is to evaluate the efficacy and safety of anti-thymocyte globulin combined with PTCy (post-HSCT cyclophosphamide, PTCy) in preventing graft-versus-host disease (GVHD) in allo-HSCT patients after anti-PD-1(anti-programmed cell death protein 1) antibody treatment. In this study, patients with hematological malignancies who needed to receive allo-HSCT after PD-1 antibody treatment were selected as the research subjects. Fludarabine and Busulfan was used as the conditioning regimen, and the dose of ATG (anti-thymocyte globulin, ATG) combined with PTCy was used as the GVHD prevention regimen. The aim of this study is to reduce the incidence of Regimen-Related Toxicity and GVHD without affecting engraftment and relapse, thereby reducing non-relapse mortality and further improving the survival of patients.

Eligibility criteria

Qualifiers

(1) age ≥ 18 years old, regardless of gender;

(2) patients with hematological malignancies (including lymphoma, leukemia, myelodysplastic syndrome, etc.) who had received at least one course of PD-1 antibody treatment;

(3) patients with indications for allo-HSCT, available donors (including matched sibling donors, haploidentical donors and unrelated donors), and no contraindications for transplantation;

(4) patients suitable for conventional Bu/Flu conditioning regimen;

Disqualifiers

(1) pregnant or lactating women;

(2) other serious conditions that may limit enrollment (e.g., advanced infection, etc.);

(3) unable to understand and follow the study protocol or sign the informed consent form.

Trial design

Treatments tested in this trial

  • Cyclophosphamid

Treatment groups

22 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators