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 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT00110006
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed newly diagnosed non-Hodgkin's lymphoma (NHL)
* Intermediate- or high-grade disease
* Stage I-IV disease
* Any of the following subtypes are allowed:
* Diffuse large B-cell lymphoma
* Anaplastic large cell lymphoma
* Mantle cell lymphoma
* Grade 3 follicular lymphoma
* Mediastinal B-cell lymphoma
* The following subtypes are not allowed:
* Lymphoblastic lymphoma
* Mycosis fungoides/Sézary's syndrome
* HTLV-1 associated T-cell leukemia or lymphoma
* Primary CNS lymphoma
* HIV-associated lymphoma
* Transformed lymphoma
* Burkitt's lymphoma
* Adequate staging of lymphoma by any of the following methods:
* CT scan or MRI of affected sites
* Unilateral or bilateral bone marrow biopsy
* Positive pre-treatment positron emission tomography (PET) scan
* Lumbar puncture
* Radiographically measurable disease by PET scan
* Any International Prognostic Index risk category allowed
* No prior diagnosis of another hematologic malignancy NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,000/mm\^3\*
* Platelet count ≥ 75,000/mm\^3\* NOTE: \*Unless due to NHL
Hepatic
* Bilirubin ≤ 2.0 mg/dL\* (excluding Gilbert's disease) NOTE: \*Unless due to NHL
Renal
* Creatinine ≤ 2.0 mg/dL (unless due to NHL)
Cardiovascular
* Ejection fraction ≥ 45% by echocardiogram or MUGA
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No other malignancy within the past 5 years except superficial nonmelanoma skin cancer or carcinoma in situ of the cervix
* No other serious co-morbid disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior rituximab for NHL
* No concurrent filgrastim \[G-CSF\] during course 1 of study treatment except for patients \> 70 years of age OR patients with active infection
Chemotherapy
* No prior chemotherapy for NHL
Endocrine therapy
* No prior steroids for NHL
Radiotherapy
* No prior radiotherapy for NHL
* Concurrent consolidation radiotherapy to sites of bulky disease allowed at the discretion of the attending physician
Surgery
* Not specified
Other
* No other prior treatment for NHL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00110006
Study Brief:
Protocol Section:
NCT00110006