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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT00381693
Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with myelofibrosis.
Detailed Description:
OBJECTIVES:
Primary
* Determine the efficacy of azacitidine in patients with myelofibrosis (MF) with myeloid metaplasia.
* Evaluate the safety of azacitidine in these patients. Secondary
* Evaluate pertinent biologic characteristics of MF before and during therapy with azacitidine.
* Assess the effects of study treatment on constitutional symptoms in these patients.
* Estimate time to event distributions for overall survival and progression. OUTLINE: Patients receive azacitidine subcutaneously once daily on days 1-5. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Study:
NCT00381693
Study Brief:
Protocol Section:
NCT00381693