Status:
TERMINATED
Azacitidine in Treating Patients With Myelofibrosis
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Secondary Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 p...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00381693
Start Date
August 1 2006
End Date
April 1 2009
Last Update
April 21 2011
Active Locations (2)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
2
Mayo Clinic
Rochester, Minnesota, United States, 55905