Clinical Trials Logo
  1. Home
  2. Hematological Malignancies
  3. NCT06238245

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

Hematological Malignancies Clinical Trial

Official title:
A Prospective, Single-Arm Clinical Study of Anti-thymocyte Globulin-based Conditioning Regimen Combined With Post-Transplantation Cyclophosphamide for GVHD Prevention in Allogeneic HSCT After PD-1 Blockade

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06238245
Study type Interventional
Source Beijing 302 Hospital
Contact Xiaoning Gao, Doctor
Phone +86-010-66947169
Email gaoxn@263.net
Status Not yet recruiting
Phase Phase 2
Start date February 28, 2024
Completion date June 30, 2026
View Details
See also
  Status Clinical Trial Phase
Terminated NCT03248479 - Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies Phase 1
Recruiting NCT05454241 - CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies Phase 2
Recruiting NCT06041815 - Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies
Active, not recruiting NCT05005442 - A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004) Phase 2
Recruiting NCT02300571 - Observational Study of the Combination of Post-transplant High Dose Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-versus-Host Disease in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant N/A
Active, not recruiting NCT01428973 - Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens Phase 2
Completed NCT00379587 - Rituximab for Prevention of Chronic GVHD Phase 1/Phase 2
Terminated NCT00506948 - Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute Graft-Versus-Host Disease (GVHD) Phase 2
Completed NCT01162096 - Reduced Intensity Haploidentical Transplant for Hematological Malignancies Phase 1/Phase 2
Active, not recruiting NCT04557098 - A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma Phase 2
Recruiting NCT04283097 - Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects Phase 1
Completed NCT03067155 - CMV Specific T Cell Therapy After Allogeneic Stem Cell Transplantation. Phase 2
Completed NCT01725555 - A Study to Assess the Effect of Food on the Bioavailability of the IGF-1R Inhibitor AXL1717 in Patients With Advanced Malignant Tumors Phase 1
Completed NCT00438178 - Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies Phase 1
Completed NCT03711604 - Compassionate Use Study of Tenalisib (RP6530) Phase 1/Phase 2
Withdrawn NCT01168882 - Safety and Tolerability of RGB-286638 in Patients With Selected, Relapsed or Refractory Hematological Malignancies Phase 1
Completed NCT01246206 - Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT Phase 2
Completed NCT01172132 - The Use of Intensive Care in Critically Ill Cancer Haematological Patients: "TRIAL-OH" N/A
Completed NCT00506402 - A Phase 1 Study of MKC-1 in Patients With Refractory Hematologic Malignancies Phase 1
Active, not recruiting NCT00163644 - RCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMT N/A