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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT00002835
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of previously untreated intermediate-grade or immunoblastic lymphoma
* Tumor score of 3 or greater, defined by the presence of 3 or more of the following criteria :
* Ann Arbor stage III or IV disease
* B symptoms (fever, sweats, and weight loss greater than 10%)
* At least 1 tumor mass greater than 7 cm or mediastinal mass visible on plain chest x-ray
* Beta-2 microglobulin at least 3.0
* Lactic dehydrogenase at least 1.1 times the upper limit of normal
* T- and B-cell lymphomas allowed if intermediate grade or immunoblastic
* Divergent histologies, including bone marrow involvement, allowed
* CNS involvement allowed 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:
* 15 to 59
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin less than 2.0 mg/dL (unless elevation due to lymphoma)
Renal:
* Creatinine no greater than 1.5 mg/dL (unless elevation due to lymphoma)
Cardiovascular:
* LVEF greater than 50% by echocardiogram if over age 45
* No congestive heart failure, angina, history of myocardial infarction, or arrhythmia unless cleared by principal investigator after cardiology consultation
Pulmonary:
* No history of chronic obstructive or restrictive lung disease
* Pulmonary consultation required for smokers or patients with questionable lung function
Other:
* HIV negative
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior malignancy with poor prognosis (less than 90% probability of surviving for 5 years)
* No geographic, economic, emotional, or social condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior biologic therapy
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* No prior endocrine therapy
Radiotherapy
* No prior radiotherapy
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
59 Years
Study:
NCT00002835
Study Brief:
Protocol Section:
NCT00002835