NCT00488436

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Antithymocyte globulin
DRUG	Cyclosporine

Timeline

• Start date: 2002-05-01
• Primary completion: 2007-06-01
• Completion: 2007-12-01
• First posted: 2007-06-20
• Last updated: 2008-11-19

Locations

11 sites across 1 country: Spain