NCT Number: NCT00488436
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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Notify MeKey information
Conditions
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
cyclosporine
DrugPrimary outcomes
-
Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine in patients with low risk myelodysplastic syndrome
Time frame: 3 years
Sponsors and collaborators
Lead sponsor
PETHEMA Foundation
Other
Registry information
Official study title
SMD/ATG-CSA: Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome
Important dates
- Study start
- 2002
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Jun 20, 2007
- Registry last updated
- Nov 19, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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