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

Phase 4

Completed

• Conditions: Myelodysplastic Syndrome

• Registration Number: NCT00488436
• Lead Sponsor: PETHEMA Foundation

Brief 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

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2007-06
• Study First Submitted: 2007-06-19
• Study First Submitted QC: 2007-06-19
• Study First Posted: 2007-06-20
• Study Completion: 2007-12
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-17
• Last Update Posted: 2008-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine in patients with low risk myelodysplastic syndrome	3 years

Trial Locations

Locations (11)

Hospital de Cabueñes; 🇪🇸 Asturias, Spain

Hospital Virgen de la Victoria; 🇪🇸 Malaga, Spain

Hospital germans Trias i Pujol; 🇪🇸 Badalona, Spain

Hospital de Basurto; 🇪🇸 Bilbao, Spain

Hospital Materno Infantil de Las Palmas; 🇪🇸 Las Palmas de Gran Canaria, Spain

Hospital Arnau de Vilanova; 🇪🇸 Valencia, Spain

Hospital de Navarra; 🇪🇸 Pamplona, Spain

Hospital Ntra Sra del Rossell; 🇪🇸 Cartagena, Spain

Hospital Morales Messeguer; 🇪🇸 Murcia, Spain

Hospital Dr Pesset; 🇪🇸 Valencia, Spain

Hospital Clinico Universitario; 🇪🇸 Zaragoza, Spain