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

January 8, 2010
January 23, 2012
January 2007
January 2012   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01045889 on ClinicalTrials.gov Archive Site
Partial and complete responses [ Time Frame: Evaluation of response one month after peripheral blood transplantation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
High Dose Therapy and Peripheral Blood Stem Cell Transplantation in HIV Related Non Hodgkin Lymphoma (NHL) at High Risk
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

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).

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).

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV-related Lymphoma
  • HIV Infections
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
Not Provided
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. Epub 2009 May 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
43
January 2014
January 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years to 60 Years
No
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
Italy
 
NCT01045889
ema2_LNH e HIV
Yes
Giuseppe Rossi, Azienda Ospedaliera Spedali Civili di Brescia
Azienda Ospedaliera Spedali Civili di Brescia
Not Provided
Principal Investigator: Giuseppe Rossi, MD Haematology Division - AO Spedali Civili di Brescia - Italy
Azienda Ospedaliera Spedali Civili di Brescia
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP