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 @ 6:54 PM
Ignite Modification Date:
2025-12-24 @ 6:54 PM
NCT ID:
NCT00003757
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven hairy cell leukemia (HCL)
* Classic HCL
* Hairy cells in the bone marrow and/or peripheral blood which co-express CD20/CD25 or CD20/CD11c, and/or which are positive for tartrate resistant acid phophatase (TRAP)
* Prolymphocytic HCL variant
* Lymphoid cells in the bone marrow and/or peripheral blood with morphology intermediate between typical hairy cells and prolymphocytes, which co-express CD20/CD11c but lack CD25 expression, and which are negative for TRAP
* Progressive or recurrent disease after prior treatment with cladribine
* Greater than 1 month since standard dose cladribine OR
* Greater than 3 months since low dose cladribine
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* WHO 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
Renal:
* Creatinine no greater than 2.3 mg/dL
Cardiovascular:
* No serious cardiac disease
Other:
* No acute or chronic infection
* HIV negative
* No psychosis
* Not pregnant or nursing
* No other prior or concurrent malignancy except carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* Recovered from prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* Recovered from prior therapy
* No concurrent cytoreductive therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003757
Study Brief:
Protocol Section:
NCT00003757