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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:
Azienda Ospedaliera Spedali Civili di Brescia
Information provided by (Responsible Party):
Giuseppe Rossi, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier:
NCT01045889
First received: January 8, 2010
Last updated: August 18, 2016
Last verified: August 2016
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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:
Drug Information available for:
Rituximab
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Lymphoma AIDS Related
B-cell Lymphoma
U.S. FDA Resources
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:
|
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 (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
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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
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | January 8, 2010 |
| Last Updated: | August 18, 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 |
ClinicalTrials.gov processed this record on August 17, 2017