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

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.

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Key information

Conditions

Myelodysplastic Syndrome Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de Cabueñes, Asturias, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan