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

Phase 3

Completed

• Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia
• Interventions: Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)

• Registration Number: NCT00678275
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-15
• Primary Completion: 2014-02
• Study Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-12
• Last Update Posted: 2015-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	ATG FRESENIUS (Anti-Lymphocyte-Globulin)	Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, NOT RECEIVING ATG in conditioning regimen
A	ATG FRESENIUS (Anti-Lymphocyte-Globulin)	Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, RECEIVING ATG in conditioning regimen

Primary Outcome Measures

Name	Time	Method
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	2 years after transplantation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany