Graft-versus-host Disease Clinical Trial
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.
To evaluate if rapamune + tacrolimus immunosuppressive prophylaxis is better than the established therapy using cyclosporine and methotrexate, a Nordic prospective multicenter randomized study will be performed. Patients will be randomized to treatment with rapamune combined with tacrolimus, or the established therapy using cyclosporine and methotrexate.
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
1. Time to neutrophils >0.5 x 109/L.
2. Time to platelets >20 x 109/L and 50 x 109/L.
3. Platelet level 30 days after transplant.
4. Transfusion requirements of platelets, erythrocytes, granulocyte transfusions during
the first 30 days.
5. Non-engraftment (graft failure/rejection).
6. Grade of acute GVHD.
7. Incidence of chronic graft-versus-host disease graded as limited or extensive and mild,
moderate and severe.
8. Transplant-related mortality.
9. Probability of relapse in patients with haematological malignancies.
10. Survival.
11. Relapse-free survival.
12. Infections by bacteria, virus and fungi. Cytomegalovirus reactivation is also followed
by PCR.
13. 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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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