NCT01045889

High Dose Therapy and Peripheral Blood Stem Cell Transplantation in HIV Related Non Hodgkin Lymphoma (NHL) at High Risk

First Line Treatment in HIV-related Large Cell Non Hodgkin Lymphoma at "High Risk", Including Early Consolidation With High Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy of an intensified first-line treatment, with conventional chemotherapy (CHOP) plus monoclonal antibody anti CD20, followed by high dose chemotherapy and PBSC transplantation in HIV-related aggressive non-Hodgkin lymphoma at "high risk" , according to the international prognostic index (IPI).

Detailed description

HIV associated NHL show particularly aggressive clinical features and a worse prognosis compared to the general population. The recent introduction of highly active antiretroviral therapy (HAART)has improved HIV positive patients' clinical conditions and reduced the risk of opportunistic infections, thus making HIV+ patients more similar to HIV- patients. Several studies have shown that the early use (as first line treatment) of high dose chemotherapy (HDT) with peripheral blood stem cell transplantation (PBSCT) is superior in the HIV negative setting to conventional dose chemotherapy, at least in patients with poor prognostic factors at diagnosis. Recently, several experiences have shown the feasibility, safety and efficacy of HDT and PBSCT, in association with HAART, as salvage therapy in HIV positive patients with lymphoma who maintain a chemosensitive disease after first-line treatment failure. It is rationale therefore to explore the use of this treatment strategy earlier, within the upfront treatment of HIV-associated lymphoma, in those patients with poor prognostic factors at diagnosis, according to the international prognostic score (IPI).

Conditions

• HIV-related Lymphoma
• HIV Infections

Interventions

Type	Name	Description
OTHER	Rituximab and CHOP regimen + PBSCT

Timeline

• Start date: 2007-01-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2010-01-11
• Last updated: 2016-08-19

Locations

1 site across 1 country: Italy