Diffuse Large B Cell Lymphoma, HIV Infections
Conditions
Keywords
Diffuse large B cell lymphoma, HIV, R-CHOP, Highly active antiretroviral therapy, Treatment Experienced
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.
Interventions
DRUGR-CHOP
* 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.
DRUGHighly active antiretroviral therapy
Combined antiretroviral treatment (TARGA) wich include at lest 3 drugs. The combination should be accepted as an initial or rescue treatment.
DRUGCentral nervous system (CNS) prophylaxis
methotrexate (12 mg) cytarabine (30 mg) hydrocortisone (20 mg)
DRUGProphylaxis of opportunistic infections and support treatment
Pegfilgrastim
Sponsors
PETHEMA Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| event-free survival probability in 5 years | 5 years |
| global survival probability in 5 years | 5 years |
| 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 |
| 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 |
| 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 |
| global response and complete remission rate | 1 year |
| duration of the response | 5 years |
Countries
Spain
Outcome results
None listed