Clinical trial NCT00466258: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Diffuse Large B Cell Lymphoma
Keywords: Diffuse large B cell lymphoma
HIV
R-CHOP
Highly active antiretroviral therapy
Treatment Experienced
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2007-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI)
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: 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)
timeFrame: 6 months
Secondary outcomes:
measure: efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days
timeFrame: 1 year
measure: global response and complete remission rate
timeFrame: 1 year
measure: duration of the response
timeFrame: 5 years
measure: event-free survival probability in 5 years
timeFrame: 5 years
measure: global survival probability in 5 years
timeFrame: 5 years
measure: predictive factors of the response after 6 cycles of treatment with R-CHOP administered every 14 days in patients with DLBCL and HIV infection
timeFrame: 2 years
measure: impact of the therapeutic combination of R-CHOP and HAART in the parameters of the HIV infection (HIV viral load and CD4+ lymphocyte count)
timeFrame: 1 year
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: H. Son Llatzer
state: Baleares
city: Badalona
country: Spain
facility: Germans Trias i Pujol
state: Barcelona
city: Mataro
country: Spain
facility: Consorci Sanitari de Mataró
state: Barcelona
city: Sabadell
country: Spain
facility: H. Parc Taulí
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: H. Clínic i Provincial, Barcelona
city: Barcelona
country: Spain
facility: H. Vall d'Hebron, Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Sant Pau, Barcelona
city: Barcelona
country: Spain
facility: ICO - Duran i Reynals, Hospitalet de Llobregat
city: Girona
country: Spain
facility: ICO - Josep Trueta
city: Madrid
country: Spain
facility: H. Gregorio Marañón
city: Tarragona
country: Spain
facility: H. Joan XXIII
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Ribera Josep M, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Germans Trias i Pujol Hospital
name: Oriol Albert, Dr
role: PRINCIPAL_INVESTIGATOR
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