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 @ 12:56 PM
Ignite Modification Date:
2025-12-24 @ 12:56 PM
NCT ID:
NCT00376961
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed mantle cell lymphoma (MCL) meeting the following criteria:
* Stage III-IV or bulky stage II disease
* Confirmation of positivity for the following phenotypes by immunohistochemistry or flow cytometry:
* Cluster of differentiation antigen 19 (CD19) (or CD20)
* Cyclin D1 OR evidence of t(11;14) translocation by cytogenetic analysis or fluorescent in situ hybridization
* Newly diagnosed, previously untreated disease
* Bidimensionally measurable disease by conventional techniques
* No nonmeasurable disease only
* Adequate tumor tissue from original diagnostic specimen available
* Tissue obtained by needle aspiration or cytology not allowed
* No clinical evidence of central nervous system (CNS) involvement by lymphoma
* Co-registration on protocols SWOG-8947 and SWOG-8819 is strongly encouraged
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No peripheral neuropathy ≥ grade 2
* No hypersensitivity to bortezomib, boron, or mannitol
* No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or any other cancer for which the patient has been disease free for the past 5 years
* HIV negative
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
* More than 14 days since prior investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00376961
Study Brief:
Protocol Section:
NCT00376961