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 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 12:52 AM
NCT ID:
NCT00005867
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven previously untreated bulky stage IA or stage IB-IV aggressive non-Hodgkin's lymphoma of 1 of the following types:
* Working formulation:
* Follicular large cell
* Diffuse mixed cell
* Diffuse large cell
* Diffuse immunoblastic OR
* REAL classification:
* Diffuse large B-cell
* Peripheral T-cell
* Measurable or evaluable disease
* Good prognosis defined as no more than one of the following:
* Stage III/IV disease
* LDH greater than upper limit of normal
* ECOG/WHO 2-4
* No lymphoblastic or Burkitt's lymphoma
* No CNS involvement
PATIENT CHARACTERISTICS:
Age:
* 18 to 59
Performance status:
* See Disease Characteristics
Life expectancy:
* Not specified
Hematopoietic:
* Hemoglobin at least 10 g/dL
* Neutrophil count at least 2,000/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin, AST, and ALT no greater than 1.5 times upper limit of normal
Renal:
* Creatinine no greater than 1.7 mg/dL
Cardiovascular:
* Ejection fraction at least 50% unless dysfunction attributable to lymphoma
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other concurrent serious uncontrolled medical conditions
* No other prior malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to more than 35% of hematopoietic sites
* Concurrent consolidation radiotherapy allowed
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT00005867
Study Brief:
Protocol Section:
NCT00005867