HIV Infections, HIV-related Lymphoma
Conditions
Keywords
HIV, non hodgkin lymphoma, peripheral blood stem cell transplantation
Brief 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).
Interventions
OTHERRituximab and CHOP regimen + PBSCT
Sponsors
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* HIV positivity * Large cellhistology (DLBCL, Immunoblastic, Plasmablastic, Anaplastic lymphoma) * Age 18-60 years * Age-adjusted IPI 2-3 * Ann Arbor stage I B-IV * Written informed consent.
Exclusion criteria
* Burkitt lymphoma * Lymphoblastic lymphoma * Primary effusion lymphoma * Age-adjusted IPI 0-1 * Performance Status (WHO) \>2 (if not related to lymphoma) * Inadequate cardiac function (V.E.F. \< 50%) or clinically evident cardiac disease * Inadequate pulmonary function (DLCO \< 50% and/or O2 \< 96%) * Inadequate renal function (creatinine \> 2 mg/dl) * Inadequate liver function (AST/ALT \> 3 ULN and/or PT \< 70%, if not related to lymphoma) * Inadequate marrow function (neutrophils \< 1500/cmm; platelets \< 100.000/cmm, if not related to lymphoma) * Virologic failure to HAART (including at least one NRTI, one NNRTI and two PI) and/or CD4 count \< 50/cmm. * CNS or meningeal lymphoma * Active opportunistic infections * Pregnancy * Other evolutive malignancy (except of localized non-melanoma skin cancer and in situ portio carcinoma) * Any other condition that contraindicates this treatment program at discretion of physician * HBsAg positivity with active viral replication (HBV-DNA positivity)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 2-years |
Secondary
| Measure | Time frame |
|---|---|
| Partial and complete responses | Evaluation of response one month after peripheral blood transplantation |
Countries
Italy
Outcome results
None listed