Status:
COMPLETED
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
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 allogenei...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT00678275
Start Date
October 1 2006
End Date
March 1 2015
Last Update
May 13 2015
Active Locations (1)
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1
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246