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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PETHEMA Foundation
• Treatments: Antilymphocyte Serum; Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• Diagnosis of low or intermediate risk myelodysplastic syndrome (MDS) (or high risk patient not eligible to intensive chemotherapy or for bone marrow transplantation), excluding chronic myelomonocytic leukemia

• At less one of two following conditions:

• Transfusion dependence: 1)Packed red blood cell transfusions greater than 2 times; 2)Untransfused hemoglobin level no greater than 10 g/dL; 3)Platelet transfusions greater than 1 time

• Infection grade III or IV secondary to neutropenia

• ECOG < or = 2

Exclusion Criteria:

• Chronic myelomonocytic leukemia

• Creatinine greater than 2 mg/dl

• Bilirubin greater than 2.5 mg/dl

• History of heart failure

• History of allergy to rabbit proteins