Randomized Trial Comparing Sirolimus and Tacrolimus Versus Cyclosporine and Methotrexate as Graft-versus-host Disease (GVHD) Prophylaxis After Allogeneic Stem Cell Transplantation

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00993343
• Date of registration: 09/10/2009
• Primary sponsor: Karolinska Institutet
• Public title: Randomized Trial Comparing Sirolimus and Tacrolimus Versus Cyclosporine and Methotrexate as Graft-versus-host Disease (GVHD) Prophylaxis After Allogeneic Stem Cell Transplantation
• Scientific 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, -DRß1 Identical Related or Unrelated Donors. A Nordic Multicenter Study.
• Date of first enrolment: September 2007
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00993343
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

Sweden

Contacts

• Name: Olle Ringden, M.D. Ph.D.

• Name: Olle Ringden, M.D. Ph.D.

• Name: Olle Ringden, M.D. Ph.D.
• Affiliation: Karolinska Institutet

Key inclusion & exclusion criteria

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

Exclusion Criteria:

- Recipients of major HLA-mismatched grafts.

- Patients who are addicted to drugs or alcohol.

- Patients who receive other stem cell source than bone marrow or peripheral stem
cells, for instance cord blood transplants.

- Patients with relapse or blast crisis of their malignant disease.

- Prior allogeneic transplant using any hematopoietic stem cell source

- Seropositive for the human immunodeficiency virus (HIV)

- Uncontrolled bacterial, viral, or fungal infection (progression of clinical symptoms)
Pregnant (positive serum human chorionic gonadotropin [ß-HCG] test) or breastfeeding
within 4 weeks of study entry

- Kidney function: serum creatinine outside the normal range for age, or measured
creatinine clearance less than 40 mL/min/1.72m² within 4 weeks of study entry and
proteinuria >0.3 g/day

- Liver function: most recent direct bilirubin, ALT, or AST greater than two times the
upper limit of normal within 4 weeks of study entry

- Lung disease: in adults, FVC or FEV1 less than 60% of predicted value (corrected for
hemoglobin); in children, overt hypoxemia, as measured by an oxygen saturation of
less than 92% within 4 weeks of study entry

- Cardiac ejection fraction of less than 45% in adults and children, or less than 26%
shortening fraction in children within 4 weeks of study entry

- Cholesterol level greater than 300 mg/dL or triglyceride level greater than 300 mg/dL
while being treated, or not on appropriate lipid-lowering therapy within 4 weeks of
study entry

- Karnofsky score <70%

- Prior history of allergy to sirolimus

- Requires voriconazole at time of study entry

- Currently receiving another investigational drug unless cleared by the principal
investigator and sponsor



Age minimum: 6 Months
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Graft-Versus-Host Disease

Survival

Intervention(s)

Drug: cyclosporine/methotrexate

Drug: Sirolimus/tacrolimus

Primary Outcome(s)

The primary endpoint is grade II-IV acute GVHD [Time Frame: One year]

Secondary Outcome(s)

Relapse-free survival [Time Frame: 2 years]

Survival [Time Frame: 2 years]

Secondary ID(s)

070101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors