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Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome

Myelodysplastic Syndrome Clinical Trial

Official title:
SMD/ATG-CSA: Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome

Clinical Trial Summary

The different mechanisms of action between Antithymocyte globulin and cyclosporine can improve the effectivity when both are used in combination in patients with myelodysplastic syndrome.

Clinical Trial Description

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 ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00488436
Study type Interventional
Source PETHEMA Foundation
Contact
Status Completed
Phase Phase 4
Start date May 2002
Completion date December 2007
View Details
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