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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT00041132
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven stage III/IV or bulky stage II mantle cell lymphoma of one of the following histologic subtypes:
* Nodular
* Diffuse
* Mantle zone
* Blastic
* Newly diagnosed and previously untreated disease
* Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
* 18 to 69
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3 (50,000/mm\^3 if marrow involvement present)
Hepatic:
* Bilirubin no greater than 1.5 mg/dL (5.0 mg/dL if hepatic involvement present)
Renal:
* Creatinine no greater than 2.0 mg/dL
* Creatinine clearance greater than 50 mL/min
Cardiovascular:
* Ejection fraction at least 50% by MUGA or 2-D echocardiogram
* No significant abnormalities by EKG
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Willing to receive blood product transfusions
* No known sensitivity to E. coli-derived proteins
* No known AIDS syndrome or HIV-associated complex
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior monoclonal antibody therapy
Chemotherapy:
* No prior chemotherapy for lymphoma
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy for lymphoma
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT00041132
Study Brief:
Protocol Section:
NCT00041132