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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT00059904
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of intermediate- or high-grade non-Hodgkin's lymphoma according to the Working Formulation, including the following subtypes:
* Diffuse large cell lymphoma
* Diffuse mixed cell lymphoma
* Immunoblastic large cell lymphoma
* CD20+ disease
* Measurable progressive or refractory disease
* No primary CNS lymphoma or lymphomatous meningitis NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Lymphocyte count less than 20,000/mm\^3
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 75,000/mm\^3
* Hemoglobin at least 9.5 g/dL
Hepatic
* SGOT and SGPT no greater than 1.5 times upper limit of normal
* Bilirubin normal
* No liver disease
* Hepatitis C-seropositive patients are allowed provided they have no active disease, as demonstrated by any of the following:
* Undetectable hepatitis C viral loads
* Biopsy showing no active disease
* Normal transaminases on at least 3 different occasions within the past year
Renal
* Creatinine normal
Cardiovascular
* No clinically significant cardiac dysfunction
* No myocardial infarction within the past 6 months
* No heart failure within the past 6 months
Pulmonary
* No clinically significant pulmonary dysfunction
* Patients with prior radiotherapy to the lung or autologous transplantation must have FEV greater than 50% and DLCO greater than 50% within 8 weeks before study treatment
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No significant infections within the past 2 weeks (including pneumonia or bronchitis)
* No history of autoimmune disease
* No prior or concurrent malignancy except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, or other solid tumor curatively treated with no evidence of recurrence within the past 2 years
* No symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism
* No prior type 1 hypersensitivity or anaphylactic reactions to murine products, rituximab, or radioimmunoconjugated anti-CD20 antibody infusion
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 months since prior autologous bone marrow transplantation
* No prior allogeneic bone marrow transplantation
* No prior interleukin-2
* No prior interferon (alfa, beta, or gamma)
* No concurrent basiliximab, daclizumab, or monoclonal antibody OKT3
Chemotherapy
* More than 30 days since prior chemotherapy
* No concurrent anticancer chemotherapy
Endocrine therapy
* More than 2 weeks since prior systemic steroids
* No concurrent systemic corticosteroids
Radiotherapy
* More than 30 days since prior radiotherapy
* No concurrent radiotherapy
Surgery
* More than 30 days since prior major surgery
Other
* More than 30 days since other prior investigational drugs
* More than 30 days since prior immunosuppressive medications
* No concurrent immunosuppressive medications including the following:
* Cyclosporine
* Mycophenolate mofetil
* Tacrolimus
* Sirolimus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00059904
Study Brief:
Protocol Section:
NCT00059904