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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


Phase 2
18 Years
60 Years
Open (Enrolling)
Both
HIV-related Lymphoma, HIV Infections

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Trial Information

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).


Inclusion Criteria:



- HIV positivity

- "Large cell"histology (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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Giuseppe Rossi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Haematology Division - AO Spedali Civili di Brescia - Italy

Authority:

Italy: The Italian Medicines Agency

Study ID:

ema2_LNH e HIV

NCT ID:

NCT01045889

Start Date:

January 2007

Completion Date:

January 2014

Related Keywords:

  • HIV-related Lymphoma
  • HIV Infections
  • HIV
  • non hodgkin lymphoma
  • peripheral blood stem cell transplantation
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, AIDS-Related

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