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Clinical Trials/NCT00678275
NCT00678275
Completed
Phase 3

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

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country161 target enrollmentStarted: October 2006Last updated:
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ConditionsAcute Myeloid LeukemiaAcute Lymphoblastic Leukemia
InterventionsATG FRESENIUS (Anti-Lymphocyte-Globulin)
DrugsATG FRESENIUS (Anti-Lymphocyte-Globulin)

Overview

Phase
Phase 3
Status
Completed
Enrollment
161
Locations
1
Primary Endpoint
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
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

A

Other

Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, RECEIVING ATG in conditioning regimen

Intervention: ATG FRESENIUS (Anti-Lymphocyte-Globulin) (Drug)

B

Other

Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, NOT RECEIVING ATG in conditioning regimen

Intervention: ATG FRESENIUS (Anti-Lymphocyte-Globulin) (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • comparison of: acute GvHD/quality of life/treatment-related mortality/toxicity/ overall survival/progression-free survival/engraftment/chronic-GvHD-free survival(2 years after transplantation)
  • incidence of infection/ AEs and ADRs(2 years after transplantation)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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