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 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT00630994
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histological confirmation of primary myelofibrosis or post essential thrombocythemic or polycythemic vera myelofibrosis
* Reticulin fibrosis ≥ grade 1
* Evaluable and symptomatic disease worthy of treatment, characterized by ≥ 1 of the following:
* Anemia, defined as hemoglobin \< 11 g/dL or erythrocyte transfusion dependence
* Palpable and symptomatic splenomegaly (palpable and symptomatic hepatomegaly is acceptable if previously splenectomized)
* Severe, disease-related constitutional symptoms, including ≥ 1 of the following:
* Severe night sweats
* Fevers
* Weight loss
* Bone pain
* Absence of t(9;22) by fluorescent in situ hybridization (FISH) or standard cytogenetics OR prior demonstration of a lack of this translocation
PATIENT CHARACTERISTICS:
* Eastern Co-operative Oncology Group (ECOG) performance status 0-3
* Absolute neutrophil count (ANC) ≥ 1,000/mm³
* Platelet count ≥ 50,000/mm³
* Creatinine ≤ 2.0 mg/dL
* Direct or total bilirubin ≤ 2.0 mg/dL
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN if elevation is attributed to hepatic extramedullary hematopoiesis)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Not incarcerated in a municipality, county, state, or federal prison
* No serious medical condition or psychiatric illness that would preclude signing the informed consent
* No condition that, in the opinion of the treating physician, places the patient at unacceptable risk for study participation or confounds the ability to interpret study data
* Able to adhere to the study visit schedule and other study requirements
PRIOR CONCURRENT THERAPY:
* No other concurrent chemotherapy (e.g., hydroxyurea, thalidomide, interferon alpha, anagrelide, or other myelosuppressive agent) or experimental therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00630994
Study Brief:
Protocol Section:
NCT00630994