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
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).
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
6 months
No
Giuseppe Rossi, MD
Principal Investigator
Haematology Division - AO Spedali Civili di Brescia - Italy
Italy: The Italian Medicines Agency
ema2_LNH e HIV
NCT01045889
January 2007
January 2014
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