Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- 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
Hospital Materno Infantil de Las Palmas
🇪🇸Las Palmas de Gran Canaria, Spain
Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Morales Messeguer
🇪🇸Murcia, Spain
Hospital de Navarra
🇪🇸Pamplona, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital Dr Pesset
🇪🇸Valencia, Spain
Scroll for more (1 remaining)Hospital de Cabueñes🇪🇸Asturias, Spain