Outcomes of Patients After Allo-HSCT With Decitabine and NAC

Relapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04945096
• Other study ID #: SOOCHOW-HY-2021-1
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 1, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2021
• Source: The First Affiliated Hospital of Soochow University
• Contact: Yaqiong Tang, Dr.
• Phone: 18896588075
• Email: tangyaqiong[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Diagnosed as hematopoietic malignancy;

2. Achieved complete remission since the last chemotherapy;

3. Age 10-70 years;

4. Be willing to receive allo-HSCT, with HLA matched related or HLA matched unrelated, or HLA mismatched related donor.

Exclusion Criteria:

1. Active infections, severe organ damage (cardiac, renal and/or hepatic dysfunction greater than grade 2 according to the Common Terminology Criteria for Adverse Events V5.0), or any other conditions that make patients ineligible for allo-HSCT;

2. Allergic to acetylcysteine or decitabine.

Related Conditions & MeSH terms

• Engraft Failure
• GVHD
• Recurrence
• Relapse

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The hematological engraftment rates	The hematological engraftment rates of patients after HSCT.	1 year
Primary	GVHD rates	The GVHD rates of patients after HSCT.	1 year
Primary	Relapse rates	The relapse rates of patients after HSCT.	1 year
Secondary	Overall survival	To evaluate the overall survival (days) of patients after HSCT.	1 year
Secondary	Disease free survival	To evaluate the disease free survival (days) of patients after HSCT.	1 year