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:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT00064116
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma according to REAL classification
* Diagnosed within the past 6 weeks
* CD20+ disease
* Ann Arbor stage II, III, or IV disease or stage I bulky disease
* International Prognostic Index (IPI) score of 0 or 1
* Score 0 defined by all of the following:
* Stage I or II disease
* ECOG performance status of 0 or 1
* Lactic dehydrogenase (LDH) no greater than upper limit of normal (ULN)
* Score 1 defined by 1 of the following:
* Stage I or II disease; ECOG performance status of 0 or 1; and LDH greater than ULN
* Stage I or II disease; ECOG performance status 2 or 3; and LDH no greater than ULN
* Stage III or IV disease; ECOG performance status 0 or 1; and LDH no greater than ULN
* Previously untreated disease
* Mediastinal B-cell lymphoma allowed
* No secondary lymphoma after prior chemotherapy or radiotherapy for other malignancies
* No transformed lymphoma
* No primary CNS lymphoma
* No primary gastrointestinal (MALT) lymphoma
* No post-transplant lymphoproliferative disorder
PATIENT CHARACTERISTICS:
Age
* 18 to 60
Performance status
* See Disease Characteristics
* ECOG 0-3
Life expectancy
* At least 3 months
Hematopoietic
* Not specified
Hepatic
* Bilirubin no greater than 2.0 mg/dL\*
* Transaminases no greater than 3 times normal\*
* No active chronic hepatitis B or C infection NOTE: \*Unless related to lymphoma
Renal
* Creatinine no greater than 2 times normal\* NOTE: \*Unless related to lymphoma
Cardiovascular
* No myocardial infarction within the past 6 months
* No uncompensated heart failure
* No dilatative cardiomyopathy
* No coronary heart disease with ST segment depression on ECG
* No severe uncompensated hypertension
Pulmonary
* No chronic lung disease with hypoxemia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No known allergic reactions against foreign proteins
* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* No concurrent disease that would preclude study treatment
* No active infections requiring systemic antibiotics or antiviral medications
* No severe uncompensated diabetes mellitus
* No clinical signs of cerebral dysfunction
* No severe psychiatric disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior murine antibodies
Chemotherapy
* No other concurrent anticancer chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No concurrent response-adapted (slow response or unconfirmed complete response) radiotherapy
Surgery
* Not specified
Other
* No prior lymphoma-specific treatment
* More than 12 weeks since prior participation in another clinical trial
* No prior participation in this study
* No other concurrent study medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00064116
Study Brief:
Protocol Section:
NCT00064116