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

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

NCT ID: NCT06238245

Condition: Graft-versus-host Disease
Hematological Malignancies

Conditions: Official terms:
Hematologic Neoplasms
Graft vs Host Disease
Cyclophosphamide
Antilymphocyte Serum

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cyclophosphamid
Description: ATG (anti-thymocyte globulin, rabbit; 5 mg/kg, day -5 to -2) was used in matched sibling donor-HSCT. ATG (1.5 mg/kg, day -5; 2.5 mg/kg, day -4; mathematical function was then exploited to determine the total targeted ATG dose on day -3 to -2 based on concentrations of active ATG on day -5 to -4) was used in both haploidentical donor-HSCT and mismatched unrelated donor-HSCT. Reduced-dose PTCy (two doses of 14.5 mg/kg Cy was given on days +3 and +4 post-HSCT) was used of GVHD prophylaxis.
Arm group label: Combination of PTCy and ATG for GVHD prophylaxis

Other name: Anti-thymocyte globulin

Summary: 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.

Detailed description: ATG (anti-thymocyte globulin, rabbit; 5 mg/kg, day -5 to -2) was used in matched sibling donor-HSCT. ATG (1.5 mg/kg, day -5; 2.5 mg/kg, day -4; mathematical function was then exploited to determine the total targeted ATG dose on day -3 to -2 based on concentrations of active ATG on day -5 to -4) was used in both haploidentical donor-HSCT and unrelated donor-HSCT. Reduced-dose PTCy regimen: two doses of 14.5 mg/kg Cy were given on days +3 and +4 post-HSCT.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - (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; - (5) no serious heart, liver, kidney, lung and other important organ diseases; - (6) Eastern Cooperative Oncology Group (ECOG) performance status score 0-2; - (7) Hematopoietic stem cell transplantation comorbidity index (HCT-CI) score was 0-3; - (8) expected survival time of at least 12 weeks; - (9) women who are not pregnant or breastfeeding; - (10) voluntary participation in clinical research; They or their legal guardians were fully aware of the study and signed informed consent. Willing to follow and complete all trial procedures; Exclusion Criteria: - (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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: February 28, 2024

Completion date: June 30, 2026

Lead sponsor:
Agency: Beijing 302 Hospital
Agency class: Other

Source: Beijing 302 Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06238245