NCT04945096

Outcomes of Patients After Allo-HSCT With Decitabine and NAC

Outcomes of Patients After Allogenic Hematopoietic Cell Transplantation With Decitabine-containing Conditioning Regimen and Acetylcysteine Treatment

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 10 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The investigators will conduct this prospective and randomized clinical trial, to evaluate the hematopoietic reconstitution, GVHD and relapse rate of patients after allo-HSCT with decitabine containing conditional regimen and NAC treatment.

Detailed description

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the main curative treatment for hematological malignancy. Relapse, graft versus host disease (GVHD) and graft failure are the main causes of treatment failure. Acetylcysteine (NAC) was found to be able to enhance defective HSCs by repairing dysfunctional bone marrow endothelial cells, and overcome the exhaustion of HSCs and enhance the engraftment of HSCs. Decitabine could restore bone marrow microenvironment by repairing endothelial cells and endothelial progenitor cells, as well as cytokines and chemokines which are crucial to HSCs proliferation and differentiation, thereby promote platelet recovery after HSCT. Besides, decitabine therapy was shown to be associated with reduced incidence of GVHD, lower relapse rate, and increased overall survival in several studies. Thereby the investigators will conduct this clinical trial to evaluate the hematopoietic reconstitution, GVHD and relapse rate of patients with hematological malignancy after allo-HSCT with decitabine containing conditional regimen and NAC treatment.

Conditions

• Engraft Failure
• Relapse
• GVHD

Interventions

Type	Name	Description
DRUG	decitabine	Decitabine (20mg/m2 intravenously from day -10 to day -8 of conditional regimen)
DRUG	Acetylcysteine	Acetylcysteine: 1.2g twice a day, oral administration, from day -10 to day 365 after HSCT.
DRUG	Semustine	Semustine: 250 mg/m2/day on day -9.
DRUG	Cytarabine	Cytarabine: 2 g/m2 every 12 hours on day -8.
DRUG	Busulfan	Busulfan: 3.2mg/kg/day on day -7 to -5.
DRUG	Cyclophosphamide	Cyclophosphamide: 1.8g/m2/day on day -4 to -3.
DRUG	Cyclosporin A	Cyclosporin A: 3mg/kg/d from day -8.
DRUG	Anti-thymocyte globulin	Anti-thymocyte globulin (2mg/kg/d on day -5 to day -2) will be added for transplants with unrelated donor or HLA mismatched donor.
DRUG	Mycophenolate	Mycophenolate (500mg, oral, twice a day from day -8) will be added for transplants with unrelated donor or HLA mismatched donor.

Timeline

• Start date: 2021-07-01
• Primary completion: 2025-07-01
• Completion: 2025-12-01
• First posted: 2021-06-30
• Last updated: 2021-06-30