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Anti-thymocyte Globulins for GVHD Prophylaxis After HLA-matched Sibling Stem Cell Transplantation in Patients at 40 Years of Age or More With Hematological Malignancies


Phase 4
40 Years
60 Years
Open (Enrolling)
Both
Leukemia, GVHD, ATG, Transplantation

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Trial Information

Anti-thymocyte Globulins for GVHD Prophylaxis After HLA-matched Sibling Stem Cell Transplantation in Patients at 40 Years of Age or More With Hematological Malignancies


Prophylaxis for GVHD included CSA, MTX and MMF±ATG. In the trial group, CSA was started
intravenously on day -1, at the dosage of 3 mg/kg, and switched to oral formulation as soon
as the patient was able to take medication after engraftment. The dosage was adjusted to
maintain a trough blood level of 200-300ng/ml. MMF was administered orally, 0.25g every 12
hours, from day -1 before transplantation to day 30 after transplantation. The dosage of MTX
was 15 mg/m2, administered i.v. on day 1, and 10 mg/m2 on days 3, 6, and 11 after
transplantation. ATG (Thymoglobulin 2.5mg/kg per day i.v.) on days -2 through -1. In the
control group, CSA was started intravenously on day -1, at the dosage of 3 mg/kg, and
switched to oral formulation as soon as the patient was able to take medication after
engraftment. The dosage was adjusted to maintain a trough blood level of 200-300ng/ml. MMF
was administered orally, 0.25g every 12 hours, from day -1 before transplantation to day 30
after transplantation. The dosage of MTX was 15 mg/m2, administered i.v. on day 1, and 10
mg/m2 on days 3, 6, and 11 after transplantation.


Inclusion Criteria:



- Standard-risk of recipients with hematological malignancies (including AML-CR1,
ALL-CR1, CML-CP, MDS-RA, RARS,RCMD,RAEB-1); age from 40 to 60; having HLA-matched
sibling donor; Eastern Cooperative Oncology Group (ECOG)≤1, ejection fraction
(EF)≥50%; bilirubin≤35µmol/L; AST, and ALT lower than or equall to two-fold
baseline;creatinie≤130µmol/L.

Exclusion Criteria:

- Active, uncontrolled infection; severe allergy to ATG, including shock or laryngeal
edema; secondary stem cell transplant recipient; haplidentical recipients; matched
unrelated donor recipients; non-myeloablative condioning regimen recipients; EF<50%;
bilirubin>35µmol/L; AST, and ALT higher than two-fold baseline; creatinie>130µmol/L.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Incidence of acute GVHD, and chronic GVHD

Outcome Time Frame:

2 years

Safety Issue:

Yes

Authority:

China: Food and Drug Administration

Study ID:

2013-08

NCT ID:

NCT01856803

Start Date:

March 2013

Completion Date:

March 2016

Related Keywords:

  • Leukemia, GVHD, ATG, Transplantation
  • Graft vs Host Disease
  • Leukemia

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