CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 target
Drug / intervention
R-CHOP +3 moredrug
Likely dose
R-CHOP 750 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00466258
NCT00466258Phase 4Completed

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)

PETHEMA Foundation·interventional·Posted Apr 27, 2007·Updated Nov 25, 2009

In Brief

A Phase 4 clinical trial evaluating R-CHOP, Highly active antiretroviral therapy, and 2 other interventions for HIV Infections and Diffuse Large B Cell Lymphoma. Completed, enrolled 50 participants across 15 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 27, 2007
Enrollment StartOct 1, 2006
Primary CompletionMay 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 19.2 years ago

Interventions

R-CHOPdrug

* 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.

Highly active antiretroviral therapydrug

Combined antiretroviral treatment (TARGA) wich include at lest 3 drugs. The combination should be accepted as an initial or rescue treatment.

Central nervous system (CNS) prophylaxisdrug

methotrexate (12 mg) cytarabine (30 mg) hydrocortisone (20 mg)

Prophylaxis of opportunistic infections and support treatmentdrug

Pegfilgrastim