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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)

Primary Purpose

HIV-related Lymphoma, HIV Infections

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Rituximab and CHOP regimen + PBSCT
Sponsored by
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-related Lymphoma focused on measuring HIV, non hodgkin lymphoma, peripheral blood stem cell transplantation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • AO Spedali Civili di Brescia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R-CHOP + PBSCT

Arm Description

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

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Partial and complete responses

Full Information

First Posted
January 8, 2010
Last Updated
August 18, 2016
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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1. Study Identification

Unique Protocol Identification Number
NCT01045889
Brief Title
High Dose Therapy and Peripheral Blood Stem Cell Transplantation in HIV Related Non Hodgkin Lymphoma (NHL) at High Risk
Acronym
HDT-HIV
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-related Lymphoma, HIV Infections
Keywords
HIV, non hodgkin lymphoma, peripheral blood stem cell transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R-CHOP + PBSCT
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Rituximab and CHOP regimen + PBSCT
Other Intervention Name(s)
Mabthera, cyclophosphamide, adryamicin, vincristine, prednisone, BiCNU, etoposide, aracytin, melphalan
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
2-years
Secondary Outcome Measure Information:
Title
Partial and complete responses
Time Frame
Evaluation of response one month after peripheral blood transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Rossi, MD
Organizational Affiliation
Haematology Division - AO Spedali Civili di Brescia - Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
AO Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19451551
Citation
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.
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High Dose Therapy and Peripheral Blood Stem Cell Transplantation in HIV Related Non Hodgkin Lymphoma (NHL) at High Risk

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