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Outcomes of Patients After Allo-HSCT With Decitabine and NAC

NCT ID: NCT04945096

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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

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Engraft Failure Relapse GVHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized after the investigator has verified that all eligibility criteria have been met. Subjects will be randomized in a 1:1 ratio to either Experimental Group (Acetylcysteine + Decitabine) or Active Comparator Group (Standard Treatment).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

decitabine

Intervention Type DRUG

Decitabine (20mg/m2 intravenously from day -10 to day -8 of conditional regimen)

Acetylcysteine

Intervention Type DRUG

Acetylcysteine: 1.2g twice a day, oral administration, from day -10 to day 365 after HSCT.

Semustine

Intervention Type DRUG

Semustine: 250 mg/m2/day on day -9.

Cytarabine

Intervention Type DRUG

Cytarabine: 2 g/m2 every 12 hours on day -8.

Busulfan

Intervention Type DRUG

Busulfan: 3.2mg/kg/day on day -7 to -5.

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide: 1.8g/m2/day on day -4 to -3.

Cyclosporin A

Intervention Type DRUG

Cyclosporin A: 3mg/kg/d from day -8.

Anti-thymocyte globulin

Intervention Type DRUG

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

Intervention Type DRUG

Mycophenolate (500mg, oral, twice a day from day -8) will be added for transplants with unrelated donor or HLA mismatched donor.

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.

Group Type ACTIVE_COMPARATOR

Semustine

Intervention Type DRUG

Semustine: 250 mg/m2/day on day -9.

Cytarabine

Intervention Type DRUG

Cytarabine: 2 g/m2 every 12 hours on day -8.

Busulfan

Intervention Type DRUG

Busulfan: 3.2mg/kg/day on day -7 to -5.

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide: 1.8g/m2/day on day -4 to -3.

Cyclosporin A

Intervention Type DRUG

Cyclosporin A: 3mg/kg/d from day -8.

Anti-thymocyte globulin

Intervention Type DRUG

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

Intervention Type DRUG

Mycophenolate (500mg, oral, twice a day from day -8) will be added for transplants with unrelated donor or HLA mismatched donor.

Interventions

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decitabine

Decitabine (20mg/m2 intravenously from day -10 to day -8 of conditional regimen)

Intervention Type DRUG

Acetylcysteine

Acetylcysteine: 1.2g twice a day, oral administration, from day -10 to day 365 after HSCT.

Intervention Type DRUG

Semustine

Semustine: 250 mg/m2/day on day -9.

Intervention Type DRUG

Cytarabine

Cytarabine: 2 g/m2 every 12 hours on day -8.

Intervention Type DRUG

Busulfan

Busulfan: 3.2mg/kg/day on day -7 to -5.

Intervention Type DRUG

Cyclophosphamide

Cyclophosphamide: 1.8g/m2/day on day -4 to -3.

Intervention Type DRUG

Cyclosporin A

Cyclosporin A: 3mg/kg/d from day -8.

Intervention Type 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.

Intervention Type DRUG

Mycophenolate

Mycophenolate (500mg, oral, twice a day from day -8) will be added for transplants with unrelated donor or HLA mismatched donor.

Intervention Type DRUG

Other Intervention Names

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5-aza-2'-deoxycytidine Acetadote Methyl-CCNU Cytosine arabinoside Myleran Cytoxan Cyclosporine Thymoglobulin CellCept

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yue Han, Prof.

Role: STUDY_CHAIR

The First Affiliated Hospital of Soochow University

Central Contacts

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Yaqiong Tang, Dr.

Role: CONTACT

Phone: 18896588075

Email: [email protected]

Yue Han, Prof.

Role: CONTACT

Phone: 13901551669

Email: [email protected]

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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SOOCHOW-HY-2021-1

Identifier Type: -

Identifier Source: org_study_id