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 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT00093769
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of indolent B-cell non-Hodgkin's lymphoma of 1 of the following subtypes:
* Follicular (grade 1, 2, or 3)
* Marginal zone (extranodal, nodal, or splenic)
* CD20-positive disease
* Relapsed or progressive disease after prior anti-neoplastic therapy, as indicated by 1 of the following:
* New lesions
* Objective evidence of progression of existing lesions
* Complete response ≥ 6 months in duration after prior rituximab therapy\* NOTE: \*For patients who were previously treated with a regimen that included rituximab
* At least 1 measurable lymph node mass \> 1.5 cm in 2 perpendicular dimensions that has not been irradiated OR that has progressed since prior radiotherapy
* No active CNS lymphoma
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 50-100% OR
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 50,000/mm\^3
Hepatic
* AST and ALT ≤ 3 times upper limit of normal (ULN)
* Bilirubin ≤ 2 times ULN
Renal
* Creatinine ≤ 2 mg/dL OR
* Creatinine clearance ≥ 30 mL/min
Immunologic
* No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins or to any component of rituximab, including polysorbate 80 and sodium citrate dihydrate
* No active systemic infection requiring treatment
* No history of allergic reaction attributable to compounds containing boron or mannitol
Other
* No peripheral neuropathy or neuropathic pain ≥ grade 2
* No other malignancy within the past 5 years except completely resected basal cell or squamous cell skin cancer or an in situ malignancy
* Previously diagnosed prostate cancer allowed provided the following criteria are met:
* T1-2a, N0, M0 disease AND Gleason score ≤ 7 AND prostate specific antigen (PSA) ≤ 10 ng/mL before initial therapy
* Treated with definitive curative therapy (i.e., prostatectomy or radiotherapy) within the past 2 years
* No clinical evidence of prostate cancer AND undetectable PSA (for prostatectomy patients) or PSA \< 1 ng/mL (for patients who did not undergo prostatectomy)
* No serious medical or psychiatric illness that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* More than 10 weeks since prior radioimmunoconjugates or toxin immunoconjugates (e.g., ibritumomab tiuxetan or iodine I 131 tositumomab)
* More than 4 weeks since prior rituximab, alemtuzumab, or other unconjugated therapeutic antibody
* No concurrent prophylactic bone marrow growth factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa) during course 1 of study therapy
Chemotherapy
* More than 6 weeks since prior nitrosoureas
* No concurrent cisplatin
Endocrine therapy
* No concurrent corticosteroids (e.g., dexamethasone) except prednisone ≤ 15 mg/day or equivalent for adrenal insufficiency
Radiotherapy
* See Disease Characteristics
* See Biologic therapy
* More than 3 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* More than 2 weeks since prior major surgery
Other
* Recovered from all prior therapy
* No prior bortezomib
* More than 3 weeks since prior antineoplastic therapy
* More than 3 weeks since prior experimental therapy
* No other concurrent antineoplastic therapy
* No other concurrent investigational agents
* Concurrent participation in a non-treatment study allowed provided it does not interfere with participation in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00093769
Study Brief:
Protocol Section:
NCT00093769