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Nonapeptide-1

Melanostatine-5, White 05

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Studies 4
Trials 100
Terminated PHASE2 INTERVENTIONAL NCT00381693

Azacitidine in Treating Patients With Myelofibrosis

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: azacitidine
Type: DRUG
Description:

Primary Outcomes

Measure: Patients With Confirmed Response (Complete Remission or Partial Remission on 2 Consecutive Evaluation at Least 4 Weeks Apart) During the First 4 Months of Treatment
TimeFrame: 4 months
Description: Response Definitions: * Completion Remission (CR):complete resolution of disease-related symptoms, ultrasound-documented resolution of hepastosplenomegaly, normalization of the peripheral blood count, white cell differential, and smear, normalization of bone marrow histology including disappearance of fibrosis and osteosclerosis. Residual cytogenetic abnormalities are allowed. * Partial Remission (PR): a major response in any baseline applicable criteria (except constitutional symptoms) without progression in any other category.

Trial Information

NCT ID

NCT00381693

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Mayo Clinic

Last Updated

December 15, 2025