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 @ 5:02 PM
Ignite Modification Date:
2025-12-24 @ 5:02 PM
NCT ID:
NCT00040950
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma (NHL)
* CD20 positive by immunohistochemistry or flow cytometry
* Relapsed or refractory disease
* Bidimensionally measurable disease
* Sole site of measurable disease within a previously irradiated field allowed provided there was disease progression at that site
* No pre-existing ascites or pleural effusions
* No known CNS involvement by NHL
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* More than 3 months
Hematopoietic:
* Neutrophil count at least 1,000/mm3
* Platelet count at least 50,000/mm3
Hepatic:
* Bilirubin less than 2 mg/dL
* Transaminase less than 2 times upper limit of normal
* No hepatitis B or C
Renal:
* Creatinine less than 2 mg/dL
Cardiovascular:
* No significant cardiovascular disease
* No New York Heart Association class III congestive heart failure
* No myocardial infarction within the past 6 months
* No unstable angina
* No uncontrolled atrial or ventricular cardiac arrhythmias
Pulmonary:
* No concurrent significant pulmonary disease
Other:
* HIV negative
* No acute infection requiring antibiotics
* No fever over 38.2 degrees C within the past 3 days
* No other malignancy within the past 5 years except basal cell or noninvasive squamous cell skin cancer or carcinoma in situ of the cervix
* No pre-existing autoimmune disease or antibody-mediated disease, including:
* Systemic lupus erythematosus
* Rheumatoid arthritis
* Multiple sclerosis
* Sjogren's syndrome
* Autoimmune thrombocytopenia
* Controlled thyroid disease allowed
* Concurrent autoantibodies without clinical autoimmune disease allowed
* No history of allergic reactions attributed to compounds of similar composition to study drugs
* No other medical history, including laboratory results, that would preclude study
* No suspected or confirmed poor compliance or mental instability that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior allogeneic transplantation
* More than 30 days since prior hematopoietic growth factors (e.g., filgrastim (G-CSF) or epoetin alfa)
* More than 30 days since prior immunotherapy
* More than 90 days since prior monoclonal antibodies as monotherapy for patients who were unresponsive to treatment (30 days for patients who responded to treatment and subsequently relapsed)
* No other concurrent biological agents
* No concurrent hematopoietic growth factors (e.g., G-CSF or epoetin alfa)
Chemotherapy:
* More than 30 days since prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy:
* More than 30 days since prior systemic corticosteroids
* No concurrent systemic corticosteroids
Radiotherapy:
* See Disease Characteristics
* More than 30 days since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* Recovered from prior therapy
* At least 6 months since prior coronary angioplasty
* More than 30 days since prior immunosuppressants
* More than 30 days since prior participation in an investigational drug study
* No concurrent immunosuppressants
* No concurrent anticoagulants except aspirin at doses no greater than 325 mg/day
* No other concurrent anticancer therapy
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00040950
Study Brief:
Protocol Section:
NCT00040950