Azacitidine in Treating Patients With Myelofibrosis

Chronic Myeloproliferative Disorders Clinical Trial

Official title: Phase II Study of Azacitidine in Myelofibrosis

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Myeloproliferative Disorders
• Primary Myelofibrosis
• Secondary Myelofibrosis

• NCT number: NCT00381693
• Study type: Interventional
• Source: Mayo Clinic
• Status: Terminated
• Phase: Phase 2
• Start date: August 2006
• Completion date: April 2009