SMD/ATG-CSA: Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome
Patients are treated with:
Antithymocyte globulin (Timoglobulin SangStat)
- 2,5 mg/kg/day IV over 8 hours on days 1-4
- Total dose: 10 mg/kg
- Calculated dose adjusted to ideal weight
- Especial considerations:
Paracetamol 1 gr (oral or IV) Dexclorfeniramine 5 mg IV Methylprednisolone 1 mg/kg IV 30
minutes before Timoglobulin and repeat if necessary at 4 hours - Platelet transfusion if
platelet count is < 50 x 109/L
Cyclosporine (Sandimmun Neoral)
-2,5 mg/kg/12 h over 3 months
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine in patients with low risk myelodysplastic syndrome
3 years
Sanz Guillermo, Dr
Study Director
HOSPITAL LA FE VALENCIA
Spain:Spanish Ministry of Health
SMD/ATG-CSA/2002
NCT00488436
May 2002
December 2007
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