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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:
ClinicalTrials.gov Identifier:
NCT01045889
First Posted: January 11, 2010
Last Update Posted: August 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Giuseppe Rossi, Azienda Ospedaliera Spedali Civili di Brescia
  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

Resource links provided by NLM:


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 Names:
  • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Submitted: January 8, 2010
First Posted: January 11, 2010
Last Update Posted: August 19, 2016
Last Verified: August 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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Lymphoma, B-Cell
Cyclophosphamide
Rituximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists