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)

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	R-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.
DRUG	Highly active antiretroviral therapy	Combined antiretroviral treatment (TARGA) wich include at lest 3 drugs. The combination should be accepted as an initial or rescue treatment.
DRUG	Central nervous system (CNS) prophylaxis	methotrexate (12 mg) cytarabine (30 mg) hydrocortisone (20 mg)
DRUG	Prophylaxis of opportunistic infections and support treatment	Pegfilgrastim

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-05-01
• Completion: 2009-11-01
• First posted: 2007-04-27
• Last updated: 2009-11-25

Locations

15 sites across 1 country: Spain