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
18 Years
65 Years
Both
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Outcome Time Frame:
2 years after transplantation
Safety Issue:
No
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
ATGFamilyStudy
NCT ID:
NCT00678275
Start Date:
October 2006
Completion Date:
October 2011
Related Keywords:
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Hematopoietic Stem Cell Transplantation
- Graft vs Host Disease
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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