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 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT00019032
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed T-cell large granular lymphocytic (T-LGL) leukemia associated with clinically significant hematocytopenia demonstrated by one of the following values while off growth factor support:
* Absolute neutrophil count less than 1,000/mm\^3
* Hemoglobin less than 8 g/dL
* Platelet count less than 50,000/mm\^3
* Clinically evaluable disease with peripheral blood T-LGL leukemia cells expressing the CD3+, CD8+ phenotype detectable by FACS
* Monoclonal T-cell population in peripheral blood (circulating mononuclear cells) demonstrated by TCR beta or gamma chain gene rearrangement
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 50-100%
Life expectancy:
* More than 2 months
Hematopoietic:
* See Disease Characteristics
* No active major bleeding episode within the past 4 weeks
Hepatic:
* Direct bilirubin less than 1.5 mg/dL
Renal:
* Creatinine less than 2.0 mg/dL
Other:
* No concurrent serious active infection
* Patients with fever without apparent site of infection may begin study while on antibiotics as long as the following are true:
* No pathogenic organism in culture
* Afebrile (maximum temperature less than 38°C) for at least 5 days
* HIV negative
* No other primary cancer other than basal cell skin cancer
* Not pregnant or nursing
* Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior interferon
* Concurrent filgrastim (G-CSF), sargramostim (GM-CSF), interleukin-11, or similar sustained-release/long-acting product (e.g., pegylated G-CSF) allowed if dose established at least 4 weeks prior to study participation
* No concurrent interferon
Chemotherapy:
* At least 4 weeks since prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy:
* Concurrent corticosteroids allowed if dose established at least 3 weeks prior to study participation
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* At least 1 week since completion of prior antibiotic regimen for serious infectious episode
* No other concurrent investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00019032
Study Brief:
Protocol Section:
NCT00019032