Status:
UNKNOWN
Safety Study of Calcineurin Inhibitor Free GvHD Prophylaxis in Allogeneic Stem Cell Transplantation
Lead Sponsor:
University Hospital Freiburg
Conditions:
Hematologic Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
In stem cell transplantation as treatment for malignant diseases, calcineurin inhibitors like cyclosporine A are commonly used to prevent tissue destruction (GvHD) by activated donor immune cells. The...
Eligibility Criteria
Inclusion
- Diagnosis of hematologic malignancies, indicated for allogeneic stem cell transplantation:
- acute myeloid leukemia (AML), in CR1, ≥ CR2, primary refractory, relapse
- chronic myeloid leukemia (CML), in chronic phase, in acceleration or blast crisis
- myelodysplastic syndrome (MDS), RA/RARS (transfusion dependent), RAEB, RAEB-t and CMML
- Lymphoma:
- plasmocytoma
- immunocytoma (M. Waldenström)
- chronic-lymphatic leukemia (CLL)
- additional low and high grade Non-Hodgkin Lymphoma
- Hodgkins disease
- HLA-matched (HLA-A, -B, -DRB1) related or unrelated donor available
- Signed informed consent
Exclusion
- CNS involvement by underlying disease
- Pulmonary disease with VC \< 55%, DLCO \< 40%
- Cardiac ejection fraction \< 30%, uncontrollable arrhythmia
- Creatinin \> 1,5 mg/dl or Creatinin-Clearance \< 30 ml/min
- Bilirubin \> 2 mg/dl
- Active Hepatitis B or C
- HIV serologic positive
- Pregnancy and lactation
- Pre-menstrual women without medical safe contraception
- Participation on another clinical trial in between 30 days before start or during the study only if the clinical trial interferes with the outcome measures.
- Known allergy to study medication or ingredients of the formulation
- Drug- or alcohol abuse
- Non-compliance
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00856505
Start Date
March 1 2008
End Date
March 1 2011
Last Update
March 5 2009
Active Locations (1)
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1
University Medical Center, Division Hematology/Oncology
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79104