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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT00003595
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically proven HIV-associated B cell non-Hodgkin's lymphoma, including:
* Diffuse large B cell lymphoma
* Intermediate grade diffuse large cell lymphoma
* High grade large cell immunoblastic lymphoma
* Burkitt's lymphoma
* High grade B cell lymphoma, Burkitt's like (small noncleaved lymphoma)
* No primary CNS lymphoma (parenchymal brain or spinal cord tumor)
* Evaluable disease HIV documentation may be serologic (ELISA or western blot), culture, or quantitative PCR or bDNA assay Tumors must be CD20 positive (greater than 50% cells express CD20)
* 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: Over 18
* Performance status: Karnofsky 70-100%
* Absolute neutrophil count greater than 1,000/mm3\*
* Platelet count greater than 75,000/mm3\*
\* Unless cytopenias are secondary to lymphoma
* Bilirubin less than 2.0 mg/dL (unless secondary to hepatic infiltration with lymphoma or isolated hyperbilirubinemia associated with the use of indinavir)
* SGOT or SGPT less than 7 times upper limit of normal
* Creatinine less than 2.0 mg/dL (unless due to lymphoma)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No acute, active HIV-associated opportunistic infection requiring antibiotics
* Mycobacterium avium complex allowed
* No concurrent malignancy except carcinoma in situ of the cervix, nonmetastatic nonmelanomatous skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy
PRIOR CONCURRENT THERAPY:
* Prior or concurrent epoetin alfa or filgrastim (G-CSF) allowed
* No prior colony stimulating factor therapy within 24 hours prior to chemotherapy
* No prior chemotherapy for HIV-associated non-Hodgkin's lymphoma
* At least 1 year since prior cyclophosphamide or doxorubicin
* No prior radiotherapy for HIV-associated non-Hodgkin's lymphoma
* Chronic therapy with myelosuppressive agents allowed
* Concurrent antiretroviral therapy, antifungal medications, and antibiotics allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003595
Study Brief:
Protocol Section:
NCT00003595