Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT00381693
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00381693
Study Brief:
Protocol Section:
NCT00381693