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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Treatments: Antilymphocyte Serum

Criteria

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