NCT00095784

Decitabine in Treating Patients With Myelofibrosis

A Phase II Study of Decitabine in Myelofibrosis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and how well decitabine works in treating patients with myelofibrosis, a cancer of the blood system associated with fibrosis (scar tissue) in the bone marrow that is advanced and for which there is no standard therapy. Decitabine may block the actions of some proteins that are responsible for turning certain genes off in various cancers including myelofibrosis.

Detailed description

PRIMARY OBJECTIVES: I. To determine response rate (complete and partial responses and hematological improvement) to decitabine in patients with myelofibrosis. II. To determine the safety of decitabine in patients with myelofibrosis. SECONDARY OBJECTIVES: I. To determine the effects of decitabine on specific epigenetic changes including methylation status of specific target genes and gene re-expression. II. To determine the effect of decitabine on hemoglobin F levels and on the absolute numbers of circulating cluster of differentiation (CD) 34+ progenitor cells and to investigate the potential utility of these markers as a surrogate for biologic activity of decitabine in myeloid metaplasia with myelofibrosis (MMM). OUTLINE: Patients receive decitabine subcutaneously (SC) on days 1-5 and 8-12. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.

Conditions

• Primary Myelofibrosis
• Secondary Myelofibrosis

Interventions

Type	Name	Description
DRUG	Decitabine	Given SC
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2004-09-29
• Primary completion: 2008-07-01
• Completion: 2026-02-22
• First posted: 2004-11-09
• Last updated: 2025-08-24
• Results posted: 2015-01-05

Locations

14 sites across 1 country: United States