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

PETHEMA Foundation25 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myelodysplastic Syndrome

Interventions

Antithymocyte globulinDRUG

CyclosporineDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (11)

Hospital de Cabueñes

Asturias, Spain

Hospital germans Trias i Pujol

Badalona, Spain

Hospital de Basurto

Bilbao, Spain

Hospital Ntra Sra del Rossell

Cartagena, Spain

Outcomes

Primary Outcomes

Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine in patients with low risk myelodysplastic syndrome

Time frame: 3 years

Data from ClinicalTrials.gov

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