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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT00290667
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histological diagnosis of aggressive B-cell lymphoma
* Previously untreated disease
* Stage I-IV disease
* CD20-positive disease
* Any International Prognostic Index (IPI) score
* No secondary lymphoma after prior chemotherapy or radiotherapy
* No primary CNS lymphoma
* No primary gastrointestinal (MALT) lymphoma
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* AST and ALT ≤ 3 times normal unless related to lymphoma
* Bilirubin ≤ 2 mg/dL unless related to lymphoma
* Creatinine ≤ 2 times normal unless related to lymphoma
* Fertile patients must use effective contraception
* No known allergic reactions against foreign proteins
* No active infections requiring systemically administered antibiotics or antiviral medications
* No noncompensated heart failure
* No dilatative cardiomyopathy
* No coronary heart disease with ST-segment depression in ECG
* No myocardial infarction during the past 6 months
* No chronic lung disease with hypoxemia
* No severe noncompensated hypertension
* No severe noncompensated diabetes mellitus
* No clinical signs of cerebral dysfunction
* No severe psychiatric disease
* No known HIV infection
* No active chronic hepatitis B or C infection
* No other concurrent diseases that exclude the administration of therapy as outlined by the study protocol
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 12 weeks since prior clinical trial participation
* No prior participation in this study
* No prior therapy, including murine antibody, for this cancer
* No prior organ transplantation
* No concurrent response-adapted radiotherapy ("iceberg radiotherapy")
* No other concurrent anticancer chemotherapy or other study medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
61 Years
Maximum Age:
80 Years
Study:
NCT00290667
Study Brief:
Protocol Section:
NCT00290667