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:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT00389818
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed AIDS-related B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
* Grade III follicular large cell lymphoma
* Diffuse large B-cell lymphoma
* Immunoblastic lymphoma
* Plasmablastic lymphoma
* Primary effusion lymphoma
* Previously untreated disease
* Any stage disease
* CD20 positive disease
* Must have documented HIV infection
* Documentation may be by serology (enzyme-linked immunosorbent assay, western blot), culture, or quantitative polymerase chain reaction or branched DNA assays
* Prior documentation of HIV seropositivity allowed
* Measurable or nonmeasurable disease
* Currently receiving effective highly active anti-retroviral therapy
* No primary CNS lymphoma, including parenchymal brain or spinal cord lymphoma
* No presence of leptomeningeal disease (positive cerebrospinal fluid for lymphoma) or presence of metastatic disease to brain, in terms of any mass lesion
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-2 OR Karnofsky PS 50-100%
* Life expectancy ≥ 2 months
* Absolute granulocyte (neutrophil) count ≥ 1,000/mm³ (unless secondary to lymphomatous involvement of bone marrow)
* Platelet count ≥ 75,000/mm³ (unless secondary to lymphomatous involvement of bone marrow or due to HIV-related thrombocytopenia)
* Bilirubin ≤ 2.0 mg/dL (unless elevated secondary to lymphomatous involvement of liver or biliary system or due to other HIV medications \[e.g., indinavir, tenofavir, or atazanavir\])
* SGOT ≤ 5 times upper limit of normal
* Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min (unless secondary to renal involvement by lymphoma)
* LVEF normal by MUGA or echocardiogram
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* No other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or Kaposi's sarcoma that does not require systemic therapy
* No serious, ongoing, nonmalignant disease or infection that would preclude study compliance, in the opinion of the investigator
* No history of cutaneous or mucocutaneous reactions, or diseases in the past, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for ≥ 2 days
* No acute, intercurrent infection that would preclude study treatment
* Patients with Mycobacterium avium are eligible
* No cardiovascular problems, including any of the following:
* Myocardial infarction within the past 6 months
* New York Heart Association class II-IV heart failure
* Uncontrolled angina
* Severe uncontrolled ventricular arrhythmias
* Clinically significant pericardial disease
* ECG evidence of acute ischemic or active conduction system abnormalities.
* No shortness of breath at rest
* Arterial PO\_2 ≥ 70 or pulse oximeter-derived O\_2 saturation ≥ 94% on room air (unless due to lymphomatous involvement of the lungs)
* Able to comply with study and provide adequate informed consent
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior major surgery (except diagnostic surgery)
* At least 12 months since prior rituximab unless it was only given for indications other than the treatment of aggressive lymphoma
* No prior cytotoxic chemotherapy or radiotherapy for this lymphoma
* Concurrent radiotherapy, with or without steroids, for emergency conditions secondary to lymphoma (i.e., CNS tumor or cord compression) allowed
* No zidovudine or zidovudine-containing regimen (including Combivir® or Trizivir®) during and for 2 months after completion of chemotherapy
* Concurrent erythropoietin or filgrastim (G-CSF) allowed
* Growth factor therapy must be discontinued ≥ 24 hours prior to study entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00389818
Study Brief:
Protocol Section:
NCT00389818