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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
* Cyclophosphamide 750 mg/m2 i.v. day 1 * Adriamycin 50 mg/m2 i.v. day 1 * Vincristine 1,4 mg/m2 i.v. day 1 * Prednisone 100 mg i.v or oral. days 1-5.
Combined antiretroviral treatment (TARGA) wich include at lest 3 drugs. The combination should be accepted as an initial or rescue treatment.
methotrexate (12 mg) cytarabine (30 mg) hydrocortisone (20 mg)
Pegfilgrastim
H. Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Germans Trias i Pujol
Badalona, Barcelona, Spain
H. Clínic i Provincial, Barcelona
Barcelona, Barcelona, Spain
H. Vall d'Hebron, Barcelona
Barcelona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Sant Pau, Barcelona
Barcelona, Barcelona, Spain
ICO - Duran i Reynals, Hospitalet de Llobregat
Barcelona, Barcelona, Spain
Consorci Sanitari de Mataró
Mataró, Barcelona, Spain
H. Parc Taulí
Sabadell, Barcelona, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
...and 5 more locations
treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI)
Time frame: 6 months
opportunistic and non-opportunistic infections rate after 6 cycles of treatment with R-CHOP administered every 14 days and HAART in patients with DLBCL and HIV infection
Time frame: 6 months
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)
Time frame: 6 months
efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days
Time frame: 1 year
global response and complete remission rate
Time frame: 1 year
duration of the response
Time frame: 5 years
event-free survival probability in 5 years
Time frame: 5 years
global survival probability in 5 years
Time frame: 5 years
predictive factors of the response after 6 cycles of treatment with R-CHOP administered every 14 days in patients with DLBCL and HIV infection
Time frame: 2 years
impact of the therapeutic combination of R-CHOP and HAART in the parameters of the HIV infection (HIV viral load and CD4+ lymphocyte count)
Time frame: 1 year
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