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 InfectionsDiffuse Large B Cell Lymphoma
- Registration Number
- NCT00466258
- Lead Sponsor
- PETHEMA Foundation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI) 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 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) 6 months
- Secondary Outcome Measures
Name Time Method efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days 1 year global response and complete remission rate 1 year duration of the response 5 years event-free survival probability in 5 years 5 years global survival probability in 5 years 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 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) 1 year
Trial Locations
- Locations (15)
ICO - Josep Trueta
🇪🇸Girona, Spain
H. Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario Dr. Peset
🇪🇸Valencia, Spain
H. Joan XXIII
🇪🇸Tarragona, Spain
H. Son Llatzer
🇪🇸Palma de Mallorca, Baleares, Spain
Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital de Navarra
🇪🇸Pamplona, Navarra, Spain
H. Vall d'Hebron, Barcelona
🇪🇸Barcelona, Spain
H. Clínic i Provincial, Barcelona
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
ICO - Duran i Reynals, Hospitalet de Llobregat
🇪🇸Barcelona, Spain
Hospital Sant Pau, Barcelona
🇪🇸Barcelona, Spain
Consorci Sanitari de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Consorci Sanitari de Mataró
🇪🇸Mataro, Barcelona, Spain
H. Parc Taulí
🇪🇸Sabadell, Barcelona, Spain