MedTrace Logo

Outcomes of Patients After Allo-HSCT With Decitabine and NAC

NCT04945096 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-06-30

No results posted yet for this study

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

Interventions

DRUG

decitabine

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

DRUG

Acetylcysteine

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

DRUG

Semustine

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

DRUG

Cytarabine

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

DRUG

Busulfan

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

DRUG

Cyclophosphamide

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

DRUG

Cyclosporin A

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

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.

DRUG

Mycophenolate

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2025-07-01
Completion
2025-12-01

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04945096 on ClinicalTrials.gov