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

HIV Infections Clinical Trial

— HDT-HIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045889
• Other study ID #: ema2_LNH e HIV
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2010
• Last updated: August 18, 2016
• Start date: January 2007
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Azienda Ospedaliera Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• HIV Infections
• HIV-related Lymphoma
• Lymphoma
• Lymphoma, AIDS-Related
• Lymphoma, Non-Hodgkin

Intervention

Other:
• Rituximab and CHOP regimen + PBSCT

Locations

Country	Name	City	State
Italy	AO Spedali Civili di Brescia	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Spedali Civili di Brescia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Re A, Michieli M, Casari S, Allione B, Cattaneo C, Rupolo M, Spina M, Manuele R, Vaccher E, Mazzucato M, Abbruzzese L, Ferremi P, Carosi G, Tirelli U, Rossi G. High-dose therapy and autologous peripheral blood stem cell transplantation as salvage treatment for AIDS-related lymphoma: long-term results of the Italian Cooperative Group on AIDS and Tumors (GICAT) study with analysis of prognostic factors. Blood. 2009 Aug 13;114(7):1306-13. doi: 10.1182/blood-2009-02-202762. Epub 2009 May 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		2-years	No
Secondary	Partial and complete responses		Evaluation of response one month after peripheral blood transplantation	No