Randomized Trial Comparing Sirolimus and Tacrolimus Versus Cyclosporine and Methotrexate as Graft-versus-host Disease (GVHD) Prophylaxis After Allogeneic Stem Cell Transplantation
|ClinicalTrials.gov Identifier: NCT00993343|
Recruitment Status : Completed
First Posted : October 12, 2009
Last Update Posted : April 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Graft-versus-host Disease Survival||Drug: Sirolimus/tacrolimus Drug: cyclosporine/methotrexate||Phase 3|
Primary endpoint The primary endpoint is grade II-IV acute GVHD in the two groups. GVHD is diagnosed clinically and graded from 0 to IV. The diagnosis is clinical and biopsies from skin, liver and gut is used according to the routines at each participating center.
Other study parameters
- Time to neutrophils >0.5 x 109/L.
- Time to platelets >20 x 109/L and 50 x 109/L.
- Platelet level 30 days after transplant.
- Transfusion requirements of platelets, erythrocytes, granulocyte transfusions during the first 30 days.
- Non-engraftment (graft failure/rejection).
- Grade of acute GVHD.
- Incidence of chronic graft-versus-host disease graded as limited or extensive and mild, moderate and severe.
- Transplant-related mortality.
- Probability of relapse in patients with haematological malignancies.
- Relapse-free survival.
- Infections by bacteria, virus and fungi. Cytomegalovirus reactivation is also followed by PCR.
- Side-effects. Side-effects regarding hematopoiesis, liver test, renal function, cardiac function, neurology, endocrinology, etc., are taken from the patients' charts. These parameters are followed regularly after transplantation.
Inclusion criteria Chronic myeloid leukemia (CML) in 1st or 2nd chronic phase, acute myeloid leukemia (AML) in complete remission, acute lymphoblastic leukemia (ALL) in complete remission, myelodysplastic syndrome, chronic lymphocytic leukemia, lymphoma, non-malignant disorders, severe aplastic anemia, hemoglobinopathies and metabolic disorders
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||215 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Study Comparing Rapamune and Tacrolimus vs. Cyclosporine and Methotrexate as Immune Prophylaxis in Allogeneic Hematopoietic Stem Cell Transplantation, Using HLA-A, -B, -DRβ1 Identical Related or Unrelated Donors. A Nordic Multicenter Study.|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||April 2015|
|Active Comparator: Cyclosporine + Methotreaxte||
Standard GVHD prophylaxis
|Active Comparator: sirolimus + tacrolimus||
Standard GVHD prophylaxis
- The primary endpoint is grade II-IV acute GVHD [ Time Frame: One year ]
- Relapse-free survival [ Time Frame: 2 years ]
- Survival [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993343
|Karolinska University Hospital|
|Stockholm, Sweden, 14186|
|Principal Investigator:||Olle Ringden, M.D. Ph.D.||Karolinska Institutet|