CompletedPhase 2

Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma

United States43 participantsStarted 2007-01

Plain-language summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving combination chemotherapy together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed AIDS-related B-cell non-Hodgkin's lymphoma.

Who can participate

Age range18 Years – 120 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .

Timeframe: After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation

Duration of Response

Median Survival Time

Rate of Bacterial, Fungal, and Opportunistic Infections

Timeframe: After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation

Trial details

NCT IDNCT00389818

SponsorAIDS Malignancy Consortium

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2011-09

Results submitted2012-05-29

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