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 @ 12:16 PM
Ignite Modification Date:
2025-12-24 @ 12:16 PM
NCT ID:
NCT00079261
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of 1 of the following WHO subtypes:
* Diffuse large B large cell lymphoma (including all clinical and morphologic variants)
* Grade 3 follicular lymphoma
* Extranodal T/NK cell lymphoma, nasal type
* Enteropathy-type T cell lymphoma
* Hepato-splenic T cell lymphoma
* Peripheral T cell lymphoma, unspecified
* Angioimmunoblastic lymphoma
* Anaplastic large cell lymphoma, systemic type
* Stage II-IV disease
* At least 1 site of measurable disease (e.g., lymph node or lymph node mass)
* The following subtypes are not allowed:
* Mantle cell lymphoma
* Burkitt's lymphoma
* Precursor B or T cell lymphoma
* Primary cutaneous B or T cell lymphoma
* No CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
Age
* 18 to 70
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* WBC \> 3,000/mm\^3
* Neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
Hepatic
* Bilirubin \< 2.5 times normal (unless due to lymphoma)
* ALT and AST \< 2.5 times normal (unless due to lymphoma)
Renal
* Creatinine \< 2.0 mg/dL
Cardiovascular
* No severe cardiac disease that would preclude study participation or limit life expectancy
Pulmonary
* FEV\_1 and DLCO ≥ 75% of predicted (unless due to lymphoma)
* No severe pulmonary disease that would preclude study participation or limit life expectancy
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* No severe neurologic or metabolic disease that would preclude study participation or limit life expectancy
* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent monoclonal antibodies
Chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy
* No concurrent radiotherapy
Surgery
* Not specified
Other
* No prior cytotoxic agents
* No prior treatment for NHL
* No other concurrent anticancer therapy
* No other concurrent investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00079261
Study Brief:
Protocol Section:
NCT00079261