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:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT00002792
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Idiopathic myelofibrosis (IMF) with at least 1 poor prognosis characteristic, including but not limited to:
* Hemoglobin less than 10 g/dL
* Platelet count less than 100,000/mm\^3
* Hepatomegaly (i.e., palpable liver edge 5 cm below costal margin)
* Clinical requirement for splenectomy
* Other myeloproliferative disorders in an IMF like myelofibrotic state eligible
* No evidence of leukemic progression, e.g.:
* Greater than 15% peripheral blood blasts
* Fever or bone pain of unknown origin
* Rapidly progressing splenomegaly
* No other causes for myelofibrosis, such as:
* Collagen vascular disorder
* Lymphoma
* Granulomatous infection
* Metastatic carcinoma
* Hairy cell leukemia
* Myelodysplastic syndrome
* No active central nervous system disease
* One of the following donor/patient pairings is required:
* Donor status:
* Genotypic or phenotypic HLA-matched relative
* Maximum patient age of 65
* One antigen HLA-mismatched relative, HLA-matched unrelated donor, or one antigen HLA-mismatched unrelated donor
* Maximum patient age of 55
* Transplant on this protocol allowed for patients registered on protocol FHCRC-1106.00
PATIENT CHARACTERISTICS:
Age:
* 65 and under
Performance status:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Bilirubin no greater than 2 times normal
* SGPT no greater than 4 times normal
Renal:
* Creatinine no greater than two times normal OR
* Creatinine clearance at least 50%
Cardiovascular:
* Ejection fraction at least 50%
* Cardiac evaluation required if signs or symptoms of coronary artery disease or congestive heart failure
Other:
* HIV negative
* No active infection
* Patients excluded from this protocol are referred to protocol FHCRC-179.05
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
65 Years
Study:
NCT00002792
Study Brief:
Protocol Section:
NCT00002792