linfotargam: treatment with chemotherapy plus rituximab and highly active antiretroviral therapy in patients with diffuse large b cell lymphoma and infection with the human immunodeficiency virus (hiv)

Conditions: HIV Infections; Diffuse Large B Cell Lymphoma

Summary: main objective: * to evaluate the applicability of the treatment: 1. to evaluate the treatment toxicity according to the common terminology criteria (ctc) version 3.0 of the national cancer institute (nci). 2. to evaluate opportunistic and non-opportunistic infections after 6 cycles of treatment with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (r-chop) administered every 14 days and highly active antiretroviral therapy (haart) in patients with diffuse large b cell lymphoma (dlbcl) and hiv infection. 3. to evaluate the adherence to the treatment with 6 cycles of r-chop considering the delays in the administration of the cycles and the reductions in the doses of chemotherapy (planned dose administered in predicted term). secondary objectives: * to evaluate the efficacy of the treatment in patients with dlbcl and hiv infection after 6 cycles of treatment with r-chop administered every 14 days (r-chop/14): 1. to determine the global response and complete remission tax. 2. to evaluate the duration of the response. 3. to evaluate the probability of event-free survival in 5 years. 4. to evaluate the probability of global survival in 5 years. * to identify predictive factors of response after 6 cycles of treatment with r-chop administered every 14 days in patients with dlbcl and hiv infection. * to evaluate the impact of the therapeutic combination of r-chop and haart in the parameters of the hiv infection (hiv viral load and cd4+ lymphocyte count).

this is a clinical trial with a pharmaceutical drug used in the same conditions of authorization.

Eligibility criteria:
inclusion criteria: * patients with hiv infection diagnosed with dlbcl in any stage (i-iv according to the ann arbor classification) not previously treated for the lymphoma. * patients with cd20-positive diffuse large b-cell lymphoma * aged from 18 to 70 years old * any score of international prognostic index. (it is also applicable in patients with non-hodgkin lymphoma \[nhl\] infected with hiv.) * ecog performance status 0 to 3 * written informed consent * absolute neutrophil count \> 1.5 x 10\^9/l. * absence of synchronic or non-synchronic neoplasia with the exception of non-melanoma skin tumors or in situ cervical carcinoma. * cd4+ lymphocyte count \> 100/µl exclusion criteria: * patients with diffuse large b cell lymphoma previously treated. * patients with primary central nervous system lymphoma. * patients with burkitt or burkitt-like nhl. * cd4+ lymphocyte count \< 100/µl * opportunistic infections or other aids-related neoplasias in activity. * active drug-addiction. * pregnant or lactating women or adults of fertile age who do not use an effective contraceptive method. * patients with serious altered renal function (creatinine \> 2.5 x upper limit of normal \[uln\]) or hepatic \[bilirubin, alt or ast \> 2.5 x uln\], except if the investigators suspect that they are caused by the disease. * cardiac insufficiency with ejection fraction \< 40% * patients with serious psychiatric diseases that can interfere with their capacity to understand the study (including alcoholism or active drug-addiction). * ecog \> 3 * patients with a known hypersensitivity to murine proteins or any other component of the study drugs.

Keywords: diffuse large b cell lymphoma hiv r-chop highly active antiretroviral therapy treatment experienced