NCT00381693

Azacitidine in Treating Patients With Myelofibrosis

Phase II Study of Azacitidine in Myelofibrosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Myeloproliferative Disorders
• Secondary Myelofibrosis

Interventions

Type	Name	Description
DRUG	azacitidine

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-03-01
• Completion: 2009-04-01
• First posted: 2006-09-28
• Last updated: 2011-04-21
• Results posted: 2011-01-24

Locations

2 sites across 1 country: United States