Outcomes of Patients After Allo-HSCT With Decitabine and NAC

NCT04945096 | Unknown Phase 3 DMC

• 1 other identifier: SOOCHOW-HY-2021-1
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Engraft Failure; Relapse; GVHD

Outcome Measures

Primary Outcomes (3)

• The hematological engraftment rates

  The hematological engraftment rates of patients after HSCT.

  1 year

• GVHD rates

  The GVHD rates of patients after HSCT.

  1 year

• Relapse rates

  The relapse rates of patients after HSCT.

  1 year

Secondary Outcomes (2)

• Overall survival

  1 year

• Disease free survival

  1 year

Study Arms (2)

Acetylcysteine + decitabine

EXPERIMENTAL

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; Drug: Acetylcysteine; Drug: Semustine; Drug: Cytarabine; Drug: Busulfan; Drug: Cyclophosphamide; Drug: Cyclosporin A; Drug: Anti-thymocyte globulin; Drug: Mycophenolate

Standard Treatment

ACTIVE COMPARATOR

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; Drug: Cytarabine; Drug: Busulfan; Drug: Cyclophosphamide; Drug: Cyclosporin A; Drug: Anti-thymocyte globulin; Drug: Mycophenolate

Interventions

decitabine DRUG

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

Also known as: 5-aza-2'-deoxycytidine

Acetylcysteine + decitabine

Acetylcysteine DRUG

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

Also known as: Acetadote

Acetylcysteine + decitabine

Semustine DRUG

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

Also known as: Methyl-CCNU

Acetylcysteine + decitabine; Standard Treatment

Cytarabine DRUG

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

Also known as: Cytosine arabinoside

Acetylcysteine + decitabine; Standard Treatment

Busulfan DRUG

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

Also known as: Myleran

Acetylcysteine + decitabine; Standard Treatment

Cyclophosphamide DRUG

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

Also known as: Cytoxan

Acetylcysteine + decitabine; Standard Treatment

Cyclosporin A DRUG

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

Also known as: Cyclosporine

Acetylcysteine + decitabine; Standard Treatment

Anti-thymocyte globulin 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.

Also known as: Thymoglobulin

Acetylcysteine + decitabine; Standard Treatment

Mycophenolate DRUG

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

Also known as: CellCept

Acetylcysteine + decitabine; Standard Treatment

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as hematopoietic malignancy;
• Achieved complete remission since the last chemotherapy;
• Age 10-70 years；
• Be willing to receive allo-HSCT, with HLA matched related or HLA matched unrelated, or HLA mismatched related donor.

You may not qualify if:

• 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;
• Allergic to acetylcysteine or decitabine.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

MeSH Terms

Conditions

Recurrence

Interventions

Decitabine; Acetylcysteine; Semustine; Cytarabine; Busulfan; Cyclophosphamide; Cyclosporine; Antilymphocyte Serum; thymoglobulin; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Lomustine; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Arabinonucleosides; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• Yue Han, Prof.

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Yaqiong Tang, Dr.

CONTACT

18896588075; tangyaqiong@suda.edu.cn

Yue Han, Prof.

CONTACT

13901551669; hanyue@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: June 30, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 30, 2021

Record last verified: 2021-04