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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT00012051
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed relapsed B-cell non-Hodgkin's lymphoma (NHL)
* Diffuse large cell B-cell lymphoma
* Grade III follicular center-cell lymphoma
* Primary mediastinal B-cell lymphoma
* CD20 positive
* First relapse after doxorubicin containing regimen
* Documented remission of at least 3 months after first-line chemotherapy
* No Epstein-Barr virus post-transplantation lymphoproliferative disorder
* No CNS involvement
PATIENT CHARACTERISTICS:
Age:
* 18 to 65
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* No hepatic dysfunction
* Bilirubin less than 2.5 times upper limit of normal (ULN)
* Transaminases less than 2.5 times ULN
Renal:
* No renal dysfunction
* Creatinine less than 2.0 mg/dL OR
* Creatinine clearance greater than 40 mL/min
Cardiovascular:
* No severe cardiac dysfunction
* No New York Heart association class II-IV heart disease
Pulmonary:
* No severe pulmonary dysfunction
* Vital capacity or diffusion capacity at least 70% predicted unless related to NHL involvement
Other:
* No active uncontrolled infection
* HIV negative
* No intolerance to exogenous protein administration
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 1 month since prior immunotherapy
Chemotherapy:
* See Disease Characteristics
* At least 1 month since prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 1 month since prior radiotherapy
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00012051
Study Brief:
Protocol Section:
NCT00012051