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 @ 1:30 PM
Ignite Modification Date:
2025-12-24 @ 1:30 PM
NCT ID:
NCT00039195
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed aggressive diffuse large B-cell lymphoma
* CD20-positive disease
* Age-adjusted International Prognostic Index II or III defined by the presence of at least 1 of the following:
* Karnofsky performance status 10-70%
* Lactate dehydrogenase greater than 200 U/L
* Stage III or IV disease
* Positron emission tomography avid measurable disease
* No CNS involvement
PATIENT CHARACTERISTICS:
Age:
* 18 to 64
Performance status:
* See Disease Characteristics
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 50,000/mm\^3
Hepatic:
* Bilirubin less than 2.0 mg/dL unless history of Gilbert's disease or pattern consistent with Gilbert's disease
* Hepatitis B surface antigen and hepatitis C antibody negative
* No chronic, active, or persistent hepatitis
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
* No chronic renal insufficiency
Cardiovascular:
* Ejection fraction at least 50% by echocardiogram or MUGA scan
* No myocardial infarction within the past 6 months
* No unstable angina
* No cardiac arrhythmias except chronic atrial fibrillation
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* HIV negative
* No other medical illness that would preclude study
* No uncontrolled infection
* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic therapy for malignancy
Chemotherapy:
* No prior chemotherapy for malignancy
Endocrine therapy:
* Prior steroids allowed if received no more than 1 week of therapy
Radiotherapy:
* No prior radiotherapy for malignancy
Surgery:
* No prior surgery for malignancy
Other:
* No other prior therapy for malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00039195
Study Brief:
Protocol Section:
NCT00039195