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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2006-006577-25-SE
Date of registration: 11/06/2007
Prospective Registration: Yes
Primary sponsor: Karolinska Institutet
Public 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, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in 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, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantation
Date of first enrolment: 25/07/2007
Target sample size: 200
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006577-25
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no  
Phase: 
Countries of recruitment
Finland Sweden
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
Patients who receives bone marrow or peripheral blood stem cells from an HLA-identical sibling donor or an unrelated genomically matched HLA-A, -B and -DRb1 identical donor. No more than one alleles mismatch is allowed. The study includes children and adults undergoing full myeloablative or non-myeloablative conditioning, according to established protocols. 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. More or less all diagnoses where there is an indication for hematopoietic stem cell transplantation with a related or unrelated HLA-identical donor may be included in the study. The inclusion of various cohorts of patients is at the discretion of each participating center – i.e., some centers may only want to include unrelated donors, other may want to include related and unrelated donors, and other centers may be more specific with regard to the various diagnoses
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Graft versus host disease prophylaxis in patients receiving stem cell transplantation due to: 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
MedDRA version: 9.1 Level: LLT Classification code 10018799 Term: GVHD
Intervention(s)

Trade Name: Rapamune
Product Name: Rapamune
Pharmaceutical Form: Tablet
INN or Proposed INN: SIROLIMUS
CAS Number: 53123889
Other descriptive name: Rapamycin
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 3-12

Trade Name: Prograf
Product Name: Prograf
Pharmaceutical Form: Capsule*
INN or Proposed INN: TACROLIMUS
CAS Number: 104987113
Other descriptive name: FK-506
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 5-15

Trade Name: Sandimmun Neoral
Product Name: Sandimmun Neoral
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865133
Other descriptive name: CsA
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 100-300

Trade Name: Methotrexate
Product Name: Methotrexate
Pharmaceutical Form: Injection*
INN or Proposed INN: METHOTREXATE
CAS Number: 59052
Other descriptive name: MTX
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)
Main Objective: To evaluate if the immunosuppressive prophylaxis with tacrolimus and sirolimus is better than the established therapy using cyclosporine and methotrexate in preventing graft versus host disease
Primary end point(s): The primary endpoint is grade II-IV acute GVHD in the two groups. GVHD is diagnosed clinically and graded from 0 to IV, according to previously published criteria. The diagnosis is clinical and biopsies from skin, liver and gut is used according to the routines at each participating center
Secondary Objective: None
Secondary Outcome(s)
Secondary ID(s)
070101
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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