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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT00006367
Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of idiopathic myelofibrosis or other myeloproliferative disorder with myelofibrosis Evidence of advanced disease or hematologic abnormalities due to severe fibrosis such as 1 or more of the following poor prognostic factors: Hemoglobin less than 10 g/dL Platelet count less than 100,000/mm3 WBC less than 4,000/mm3 Symptomatic splenomegaly Constitutional symptoms inadequately controlled with low dose chemotherapy Abnormal karyotype Patients without evidence of advanced disease undergo PBSC harvest and transplantation is delayed until there is evidence of disease progression Leukemia progression (greater than 15% peripheral blood blasts) allowed if the history of a chronic myeloproliferative disorder of at least 6 months duration is well documented Ineligible for or refusal of allogeneic transplantation No other cause of myelofibrosis other than myeloproliferative disorders, such as the following: Metastatic carcinoma Lymphoma Hairy cell leukemia Myelodysplastic syndrome De novo acute leukemia Collagen vascular disorders Granulomatous infections
PATIENT CHARACTERISTICS: Age: 75 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics WBC no greater than 30,000/mm3 (may be reduced to less than 30,000/mm3 using hydroxyurea or induction chemotherapy) Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN)\* Transaminases no greater than 2 times ULN\* \* Unless due to extramedullary hematopoiesis in the liver Renal: Creatinine no greater than 2 times normal OR Creatinine clearance at least 50% Cardiovascular: No prior or active congestive heart failure\* LVEF at least 50%\* \*If receiving study cytoreductive therapy Pulmonary: Total lung capacity at least 50% predicted OR Corrected DLCO at least 50% predicted Other: No active infection No poorly controlled seizure disorders Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 7 days since prior hydroxyurea Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT00006367
Study Brief:
Protocol Section:
NCT00006367