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 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT00070018
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes:
* Diffuse large B-cell
* Mantle cell
* High-grade B-cell, Burkitt's, or Burkitt-like
* Anaplastic large cell (B-cell phenotype only)
* Stage I, IE, or non-bulky\* stage II or IIE disease by Ann Arbor classification
* Patients who have bulky stage II or IIE disease are ineligible even if, after resection, the measurements are less than 10.0 cm NOTE: \*Non-bulky disease defined as any tumor measuring less than 10.0 cm or occupying less than 1/3 of the chest diameter
* CD20-expressing disease by flow cytometry or immunoperoxidase staining
* Aggressive lymphomas must have at least 1 of the following adverse prognostic factors:
* Non-bulky stage II or IIE disease
* At least 60 years of age
* Zubrod performance status of 2
* Lactic dehydrogenase greater than upper limit of normal
* All disease must be encompassable in a single radiation port (including any site of resected disease) 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
* Over 18
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No medical contraindication to study chemotherapy, rituximab, or ibritumomab tiuxetan
* No known AIDS syndrome or HIV-associated complex
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior monoclonal antibody therapy
Chemotherapy
* No prior chemotherapy for lymphoma
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* No prior radiotherapy for lymphoma
* No concurrent intensity-modulated radiotherapy
* Planned involved-field radiotherapy must not encompass more than 25% of active bone marrow space
Surgery
* See Disease Characteristics
Other
* Concurrent participation in SWOG-8947 or SWOG-8819 allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00070018
Study Brief:
Protocol Section:
NCT00070018