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)

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PETHEMA Foundation
• Treatments: Anti-Retroviral Agents; Rituximab

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.