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)

PETHEMA Foundation

Status and phase

Completed

Phase 4

Conditions

HIV Infections

Diffuse Large B Cell Lymphoma

Treatments

Drug: Central nervous system (CNS) prophylaxis

Drug: Highly active antiretroviral therapy

Drug: R-CHOP

Drug: Prophylaxis of opportunistic infections and support treatment

Study type

Interventional

Funder types

Other

Identifiers

LINFOTARGAM

2006-003750-23

Details and patient eligibility

About

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).

Full description

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

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.