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Spots Global Cancer Trial Database for 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)

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Trial Identification

Brief Title: 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)

Official Title: LINFOTARGAM: First-line Treatment With Dose-dense Chemotherapy Plus Rituximab (R-CHOP/14) and Highly Active Antiretroviral Therapy (HAART) in Patients With Diffuse Large B Cell Lymphoma (DLBCL) and Infection With the Human Immunodeficiency Virus (HIV)

Study ID: NCT00466258

Study Description

Brief 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).

Detailed Description: This is a clinical trial with a pharmaceutical drug used in the same conditions of authorization.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

H. Son Llatzer, Palma de Mallorca, Baleares, Spain

Germans Trias i Pujol, Badalona, Barcelona, Spain

Consorci Sanitari de Mataró, Mataro, Barcelona, Spain

H. Parc Taulí, Sabadell, Barcelona, Spain

Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain

Hospital de Navarra, Pamplona, Navarra, Spain

H. Clínic i Provincial, Barcelona, Barcelona, , Spain

H. Vall d'Hebron, Barcelona, Barcelona, , Spain

Hospital del Mar, Barcelona, , Spain

Hospital Sant Pau, Barcelona, Barcelona, , Spain

ICO - Duran i Reynals, Hospitalet de Llobregat, Barcelona, , Spain

ICO - Josep Trueta, Girona, , Spain

H. Gregorio Marañón, Madrid, , Spain

H. Joan XXIII, Tarragona, , Spain

Hospital Universitario Dr. Peset, Valencia, , Spain

Contact Details

Name: Ribera Josep M, Dr

Affiliation: Germans Trias i Pujol Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Oriol Albert, Dr

Affiliation: Germans Trias i Pujol Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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