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.

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