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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Azienda Ospedaliera Spedali Civili di Brescia.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Giuseppe Rossi, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier:
NCT01045889
First received: January 8, 2010
Last updated: January 23, 2012
Last verified: January 2012
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Azienda Ospedaliera Spedali Civili di Brescia:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Partial and complete responses [ Time Frame: Evaluation of response one month after peripheral blood transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: January 2007
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Rituximab and CHOP regimen + 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 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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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

Contacts
Contact: Giuseppe Rossi, MD +39 030 399 ext 5747 rossig@med.unibs.it
Contact: Alessandro Re, MD +39 030 399 ext 5438 sandrore@aruba.it

Locations
Italy
AO Spedali Civili di Brescia Recruiting
Brescia, Italy, 25123
Contact: Alessandro Re, MD    +39030399 ext 5438    sandrore@aruba.it   
Principal Investigator: Giuseppe Rossi, MD         
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
Study First Received: January 8, 2010
Last Updated: January 23, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Azienda Ospedaliera Spedali Civili di Brescia:
HIV
non hodgkin lymphoma
peripheral blood stem cell transplantation

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, AIDS-Related
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, B-Cell
Cyclophosphamide
Rituximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on August 26, 2014