Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT00411905
Brief Summary:
We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.
Detailed Description:
Four cycles of treatment are proposed at 28 day intervals in an ambulatory setting
Cycle 1 :
* Cytarabine 10 mg /m2/day subcutaneous injection for 14 days
* Bortézomib 1,5mg/m2 days 1,4,8,11
Cycles 2, 3, 4 :
* Cytarabine 20 mg /m2/j subcutaneous injections for 14 days
* Bortézomib 1,5mg/m2 days 1,4,8,11
Bone marrow aspirates are evaluated just before the first cycle, after the second and after the fourth cycles
Responding patients may continue the treatment for 2 further cycles
Study:
NCT00411905
Study Brief:
Protocol Section:
NCT00411905