Myeloproliferative Neoplasms Clinical Trial

Azacitidine in Treating Patients With Myelofibrosis

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.

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Full 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.

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Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed myelofibrosis with myeloid metaplasia (MMM), including any of the following subtypes:

Agnogenic myeloid metaplasia
Post-polycythemic myeloid metaplasia
Post-thrombocythemic myeloid metaplasia

Evaluable and symptomatic disease, defined as 1 of the following:

Anemia (hemoglobin < 10 g/dL or erythrocyte transfusion-dependent, requiring 1 transfusion ≤ 8 weeks)
Treatment required* for symptomatic palpable splenomegaly (palpable hepatomegaly is acceptable if previously splenectomized) NOTE: *Subjective but painful enough to mandate intervention

Absence of t(9;22) by fluorescent in situ hybridization (FISH) or standard cytogenetics (by peripheral blood or marrow)

- Previous demonstration of a lack of this translocation (at any point) is sufficient

No advanced malignant hepatic tumors

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Absolute neutrophil count ≥ 1,000/mm³
Platelet count ≥ 50,000/mm³
Creatinine ≤ 2.0 mg/dL
Total bilirubin ≤ 2.0 mg/dL OR direct bilirubin ≤ 2.0 mg/dL if total bilirubin elevated (unless attributed to underlying disease)
AST and ALT ≤ 2 times upper limit of normal (unless clinically attributed to hepatic extramedullary hematopoiesis)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No baseline peripheral or autonomic neuropathy ≥ grade 2
No condition, including the presence of laboratory abnormalities, that would preclude study compliance
No hypersensitivity to mannitol or azacitidine
Not incarcerated in a municipality (i.e., county, state, or federal prison)

PRIOR CONCURRENT THERAPY:

At least 14 days since prior chemotherapy, including interferon alfa, anagrelide, or other myelosuppressive agents
At least 14 days since prior systemic corticosteroids
At least 14 days since prior investigational agents

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

10

Study ID:

NCT00381693

Recruitment Status:

Terminated

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic in Arizona
Scottsdale Arizona, , United States
Mayo Clinic
Rochester Minnesota, 55905, United States

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

10

Study ID:

NCT00381693

Recruitment Status:

Terminated

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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