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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT00278408
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes:
* Grade 3 follicular lymphoma
* Diffuse B-cell lymphoma, including diffuse large cell lymphoma with the following variants:
* Centroblastic
* Immunoblastic
* Plasmablastic
* Anaplastic large cell
* T-cell-rich B-cell lymphoma
* Primary effusion lymphoma
* Intravascular B-cell lymphoma
* Primary mediastinal B-cell lymphoma
* Burkitt's or Burkitt-like lymphoma
* Mantle cell lymphoma (blastoid)
* Aggressive marginal zone lymphoma (monocytoid)
* Previously untreated disease
* CD20-positive disease
* International prognostic index (IPI) score 0 or 1 (age-adjusted)
* Only patients with bulky disease, as defined by largest single or conglomerate tumor ≥ 7.5 cm in diameter, are allowed to have an IPI score of 0
* No mucosa-associated lymphoid tissue (MALT) lymphoma
* No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Platelet count ≥ 100,000/mm³
* WBC ≥ 2,500/mm³
* No known hypersensitivity to the study medications
* No known HIV-positivity
* No active hepatitis infection
* Not pregnant or lactating
* Negative pregnancy test
* No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer
* No impaired left ventricular function
* No severe cardiac arrhythmias
* No other impaired organ function
* No other serious disorder
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy or radiotherapy
* No prior immunosuppressive treatment with cytostatics
* No concurrent participation in other treatment studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00278408
Study Brief:
Protocol Section:
NCT00278408