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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT00014560
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of CD19+ non-Hodgkin's lymphoma or chronic lymphocytic leukemia
* Primary refractory or multiply relapsed (after at least 2 prior chemotherapy regimens) disease
* Ineligible for bone marrow or peripheral blood stem cell transplantation
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* ECOG 0-2
Life expectancy:
* More than 3 months
Hematopoietic:
* WBC greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Absolute neutrophil count greater than 1,500/mm\^3
Hepatic:
* Bilirubin less than 1.5 mg/dL
* Alkaline phosphatase less than 2 times normal
* SGPT less than 2 times normal
Renal:
* Creatinine clearance greater than 50 mL/min
Other:
* No human-anti-murine-antibody response to prior murine monoclonal antibodies
* No immunological or inflammatory disease (e.g., lupus erythematosus)
* No active serious infection
* No other serious medical condition that would limit survival to less than 2 years
* No other active malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
* No psychiatric or addictive disorder that would preclude study
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior immunotherapy allowed
Chemotherapy:
* See Disease Characteristics
* No concurrent chemotherapy
Endocrine therapy:
* Concurrent steroids for adrenal failure or adverse reactions to study drug allowed
* Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed
Radiotherapy:
* Not specified
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00014560
Study Brief:
Protocol Section:
NCT00014560