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 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT01359592
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL)
* Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group
* Lymphoma must express CD20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections
* Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible
* Patients must have non-bulky stage I or II disease by Ann Arbor classification
* This staging excludes FDG-PET evaluation
* Patients who have stage I or II non-bulky disease on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible
* Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to registration
* Low-resolution "localization" CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol
* If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable
* Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma
* Any laboratory or radiographic tests performed to assess CNS involvement must be negative and must be performed within 42 days prior to registration
* Patients may have either measurable or evaluable limited-stage DLBCL
* Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible
* If patient has measurable disease it must be documented on the Lymphoma Baseline Tumor Assessment Form (Form #15187)
* All measurable disease must be assessed within 28 days prior to registration
* Patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration
* Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-2
* Absolute neutrophil count (ANC) ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³
* Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert syndrome)
* Patients must not be pregnant or nursing
* Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period
* Patients must not be known to be HIV-positive
* No other prior malignancy is allowed except for the following:
* Adequately treated basal cell or squamous cell skin cancer
* In situ cervical cancer
* Adequately treated stage I or II cancer from which the patient is currently in complete remission
* Any other cancer from which the patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:
* Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01359592
Study Brief:
Protocol Section:
NCT01359592