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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS Lymphoma

Drug Information available for: Rituximab

Genetic and Rare Diseases Information Center resources: B-cell Lymphomas Lymphosarcoma

U.S. FDA Resources

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:

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:

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.


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:


Lymphoma Lymphoma, AIDS-Related Lymphoma, Non-Hodgkin Immune System Diseases Immunoproliferative Disorders	Lymphatic Diseases Lymphoma, B-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 27, 2015

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