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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Azienda Ospedaliera Spedali Civili di Brescia


Information provided by (Responsible Party)
Giuseppe Rossi, Azienda Ospedaliera Spedali Civili di Brescia

ClinicalTrials.gov Identifier
NCT01045889

First received: January 8, 2010
Last updated: August 18, 2016
Last Verified: August 2016
History of Changes
Purpose

Purpose

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).

Condition Intervention Phase
HIV-related Lymphoma
HIV Infections

Other : Rituximab and CHOP regimen + PBSCT
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Giuseppe Rossi, Azienda Ospedaliera Spedali Civili di Brescia:

Primary Outcome Measures

  • Overall survival [ Time Frame: 2-years ]
Secondary Outcome Measures:
  • Partial and complete responses [ Time Frame: Evaluation of response one month after peripheral blood transplantation ]

Enrollment: 27
Study Start Date: January 2007
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: R-CHOP + PBSCT
All patients will receive chemoimmunotherapy with Rituximab + CHOP regimen for 6 cycles followed by high dose cyclophosphamide and stem cell collection, then high dose therapy with BEAM conditioning regimen and peripheral blood stem cell transplantation
Other: Rituximab and CHOP regimen + PBSCT
Other Name:
  • Mabthera
  • cyclophosphamide
  • adryamicin
  • vincristine
  • prednisone
  • BiCNU
  • etoposide
  • aracytin
  • melphalan

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).

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 60 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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)

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045889

Locations

Italy
AO Spedali Civili di Brescia
Brescia, Italy, 25123

Sponsors and Collaborators

Azienda Ospedaliera Spedali Civili di Brescia

Investigators

Principal Investigator: Giuseppe Rossi, MD Haematology Division - AO Spedali Civili di Brescia - Italy
More Information

More Information


Responsible Party: Giuseppe Rossi, Director of Hematology, Azienda Ospedaliera Spedali Civili di Brescia  
ClinicalTrials.gov Identifier: NCT01045889   History of Changes  
Other Study ID Numbers: ema2_LNH e HIV  
Study First Received: January 8, 2010  
Last Updated: August 18, 2016  

Keywords provided by Giuseppe Rossi, Azienda Ospedaliera Spedali Civili di Brescia:

HIV
non hodgkin lymphoma
peripheral blood stem cell transplantation

Additional relevant MeSH terms:
Lymphoma
HIV Infections
Lymphoma, Non-Hodgkin
Lymphoma, AIDS-Related
Cyclophosphamide
Rituximab

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.