Outcomes of Patients After Allo-HSCT With Decitabine and NAC

June 22, 2021 updated by: The First Affiliated Hospital of Soochow University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acetylcysteine + decitabine
Acetylcysteine (1.2g twice a day, oral administration, from day -10 to day 365 after HSCT). Conditional regimen: decitabine (20mg/m2 intravenously from day -10 to day -8 of conditional regimen); semustine 250 mg/m2/day on day -9; cytarabine 2 g/m2 every 12 hours on day -8; busulfan 3.2mg/kg/day on day -7 to -5; cyclophosphamide 1.8g/m2/day on day -4 to -3; cyclosporin A: 3mg/kg/d from day -8. Anti-thymocyte globulin (2mg/kg/d on day -5 to day -2) and mycophenolate (500mg, oral, twice a day from day -8) were usually added for transplants with unrelated donor or HLA mismatched donor.
Drug: decitabine
Decitabine (20mg/m2 intravenously from day -10 to day -8 of conditional regimen)
Other Names:
  • 5-aza-2'-deoxycytidine
Drug: Acetylcysteine
Acetylcysteine: 1.2g twice a day, oral administration, from day -10 to day 365 after HSCT.
Other Names:
  • Acetadote
Drug: Semustine
Semustine: 250 mg/m2/day on day -9.
Other Names:
  • Methyl-CCNU
Drug: Cytarabine
Cytarabine: 2 g/m2 every 12 hours on day -8.
Other Names:
  • Cytosine arabinoside
Drug: Busulfan
Busulfan: 3.2mg/kg/day on day -7 to -5.
Other Names:
  • Myleran
Drug: Cyclophosphamide
Cyclophosphamide: 1.8g/m2/day on day -4 to -3.
Other Names:
  • Cytoxan
Drug: Cyclosporin A
Cyclosporin A: 3mg/kg/d from day -8.
Other Names:
  • Cyclosporine
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.
Other Names:
  • Thymoglobulin
Drug: Mycophenolate
Mycophenolate (500mg, oral, twice a day from day -8) will be added for transplants with unrelated donor or HLA mismatched donor.
Other Names:
  • CellCept
Active Comparator: Standard Treatment
Conditional regimen: semustine 250 mg/m2/day on day -9; cytarabine 2 g/m2 every 12 hours on day -8; busulfan 3.2mg/kg/day on day -7 to -5; cyclophosphamide 1.8g/m2/day on day -4 to -3; cyclosporin A: 3mg/kg/d from day -8. Anti-thymocyte globulin (2mg/kg/d on day -5 to day -2) and mycophenolate (500mg, oral, twice a day from day -8) were usually added for transplants with unrelated donor or HLA mismatched donor.
Drug: Semustine
Semustine: 250 mg/m2/day on day -9.
Other Names:
  • Methyl-CCNU
Drug: Cytarabine
Cytarabine: 2 g/m2 every 12 hours on day -8.
Other Names:
  • Cytosine arabinoside
Drug: Busulfan
Busulfan: 3.2mg/kg/day on day -7 to -5.
Other Names:
  • Myleran
Drug: Cyclophosphamide
Cyclophosphamide: 1.8g/m2/day on day -4 to -3.
Other Names:
  • Cytoxan
Drug: Cyclosporin A
Cyclosporin A: 3mg/kg/d from day -8.
Other Names:
  • Cyclosporine
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.
Other Names:
  • Thymoglobulin
Drug: Mycophenolate
Mycophenolate (500mg, oral, twice a day from day -8) will be added for transplants with unrelated donor or HLA mismatched donor.
Other Names:
  • CellCept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The hematological engraftment rates
Time Frame: 1 year
The hematological engraftment rates of patients after HSCT.
1 year
GVHD rates
Time Frame: 1 year
The GVHD rates of patients after HSCT.
1 year
Relapse rates
Time Frame: 1 year
The relapse rates of patients after HSCT.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year
To evaluate the overall survival (days) of patients after HSCT.
1 year
Disease free survival
Time Frame: 1 year
To evaluate the disease free survival (days) of patients after HSCT.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

  • Study Chair: Yue Han, Prof., The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

April 25, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Actual)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOOCHOW-HY-2021-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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