Chronic Graft-versus-host Disease (cGvHD) Prophylaxis With or Without ATG Prior to Stem Cell Transplantation (SCT) From HLA-identical Siblings in Patients With Acute Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00678275
First received: May 8, 2008
Last updated: May 12, 2015
Last verified: May 2015

May 8, 2008
May 12, 2015
October 2006
February 2014   (final data collection date for primary outcome measure)
comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic SCT from HLA-identical siblings with or without anti-T-lymphocyte-globulin at 2 years after transplantation [ Time Frame: 2 years after transplantation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00678275 on ClinicalTrials.gov Archive Site
  • comparison of: acute GvHD/quality of life/treatment-related mortality/toxicity/ overall survival/progression-free survival/engraftment/chronic-GvHD-free survival [ Time Frame: 2 years after transplantation ] [ Designated as safety issue: No ]
  • incidence of infection/ AEs and ADRs [ Time Frame: 2 years after transplantation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Chronic Graft-versus-host Disease (cGvHD) Prophylaxis With or Without ATG Prior to Stem Cell Transplantation (SCT) From HLA-identical Siblings in Patients With Acute Leukemia
Prophylaxis of Chronic Graft-versus-host Disease (cGvHD) With or Without Anti-T-lymphocyte-globulin (ATG Fresenius) Prior Allogeneic Peripheral Stem Cell Transplantation From HLA-identical Siblings After Myeloablative Conditioning in Patients With Acute Leukemia: A Randomized Phase III-study

This multicenter, prospective phase III-study is to compare the administration of ATG FRESENIUS to the NON-administration of ATG FRESENIUS in a myeloablative conditioning regimen followed by allogeneic hematopoeitic stem cell transplantation from an HLA-identical sibling in patients with acute Leukemia. This clinical trial is to show that the administration of ATG FRESENIUS reduces the risk of chronic Graft-versus-Host disease after allogeneic stem cell transplantation from HLA-identical siblings.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)
    conditioning regimen with ATG: ATG FRESENIUS dosing: 10mg/kg/day, (day -3, -2,-1) when randomised Arm A
  • Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)
    conditioning regimen WITHOUT ATG when randomised Arm B
  • A
    Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, RECEIVING ATG in conditioning regimen
    Intervention: Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)
  • B
    Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, NOT RECEIVING ATG in conditioning regimen
    Intervention: Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
161
March 2015
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Acute myeloid leukemia in first or subsequent complete remission (de-novo or secondary AML)
  • Acute lymphoblastic leukemia in first or subsequent complete remission
  • Patient's age: 18 - 65 years
  • Myeloablative standard conditioning
  • HLA-identical sibling (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1)
  • No major organ dysfunctions
  • Patient's written consent

Exclusion Criteria:

  • No complete remission at time of randomization
  • Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as

    • Total bilirubin, SGPT or SGOT 5 times upper the normal level
    • left ventricular ejection fraction <30%
    • Creatinine clearance <30 ml/min
    • DLCO <35% and/or receiving supplementary continuous oxygen
  • Positive serology for HIV
  • Pregnant or lactating women
  • Serious psychiatric or psychological disorders
  • Progressive invasive fungal infection at time of registration
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00678275
ATGFamilyStudy
No
Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
Not Provided
Principal Investigator: Nicolaus Kroeger, Prof. Dr. University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
Universitätsklinikum Hamburg-Eppendorf
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP