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

PETHEMA Foundation

Status and phase

Completed

Phase 4

Conditions

Myelodysplastic Syndrome

Treatments

Drug: Cyclosporine

Drug: Antithymocyte globulin

Study type

Interventional

Funder types

Other

Identifiers

NCT00488436

SMD/ATG-CSA/2002

Details and patient eligibility

About

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.

Full 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

Enrollment

25 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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