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Outcomes of Patients After Allo-HSCT With Decitabine and NAC

22. juni 2021 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

100

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

10 år til 70 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: decitabine
Decitabine (20mg/m2 intravenously from day -10 to day -8 of conditional regimen)
Andre navne:
  • 5-aza-2'-deoxycytidin
Medicin: Acetylcysteine
Acetylcysteine: 1.2g twice a day, oral administration, from day -10 to day 365 after HSCT.
Andre navne:
  • Acetadot
Medicin: Semustine
Semustine: 250 mg/m2/day on day -9.
Andre navne:
  • Methyl-CCNU
Medicin: Cytarabine
Cytarabine: 2 g/m2 every 12 hours on day -8.
Andre navne:
  • Cytosin arabinosid
Medicin: Busulfan
Busulfan: 3.2mg/kg/day on day -7 to -5.
Andre navne:
  • Myleran
Medicin: Cyclophosphamide
Cyclophosphamide: 1.8g/m2/day on day -4 to -3.
Andre navne:
  • Cytoxan
Medicin: Cyclosporin A
Cyclosporin A: 3mg/kg/d from day -8.
Andre navne:
  • Cyclosporin
Medicin: 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.
Andre navne:
  • Thymoglobulin
Medicin: Mycophenolate
Mycophenolate (500mg, oral, twice a day from day -8) will be added for transplants with unrelated donor or HLA mismatched donor.
Andre navne:
  • CellCept
Aktiv komparator: 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.
Medicin: Semustine
Semustine: 250 mg/m2/day on day -9.
Andre navne:
  • Methyl-CCNU
Medicin: Cytarabine
Cytarabine: 2 g/m2 every 12 hours on day -8.
Andre navne:
  • Cytosin arabinosid
Medicin: Busulfan
Busulfan: 3.2mg/kg/day on day -7 to -5.
Andre navne:
  • Myleran
Medicin: Cyclophosphamide
Cyclophosphamide: 1.8g/m2/day on day -4 to -3.
Andre navne:
  • Cytoxan
Medicin: Cyclosporin A
Cyclosporin A: 3mg/kg/d from day -8.
Andre navne:
  • Cyclosporin
Medicin: 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.
Andre navne:
  • Thymoglobulin
Medicin: Mycophenolate
Mycophenolate (500mg, oral, twice a day from day -8) will be added for transplants with unrelated donor or HLA mismatched donor.
Andre navne:
  • CellCept

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The hematological engraftment rates
Tidsramme: 1 year
The hematological engraftment rates of patients after HSCT.
1 year
GVHD rates
Tidsramme: 1 year
The GVHD rates of patients after HSCT.
1 year
Relapse rates
Tidsramme: 1 year
The relapse rates of patients after HSCT.
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival
Tidsramme: 1 year
To evaluate the overall survival (days) of patients after HSCT.
1 year
Disease free survival
Tidsramme: 1 year
To evaluate the disease free survival (days) of patients after HSCT.
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The First Affiliated Hospital of Soochow University

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. juli 2021

Primær færdiggørelse (Forventet)

1. juli 2025

Studieafslutning (Forventet)

1. december 2025

Datoer for studieregistrering

Først indsendt

25. april 2021

Først indsendt, der opfyldte QC-kriterier

22. juni 2021

Først opslået (Faktiske)

30. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SOOCHOW-HY-2021-1

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