High Dose Therapy and Peripheral Blood Stem Cell Transplantation in HIV Related Non Hodgkin Lymphoma (NHL) at High Risk (HDT-HIV)
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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: | 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 |
- Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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) |
-
Other: Rituximab and CHOP regimen + PBSCT
- Mabthera
- cyclophosphamide
- adryamicin
- vincristine
- prednisone
- BiCNU
- etoposide
- aracytin
- melphalan
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 |
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| 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 | |
| AO Spedali Civili di Brescia | Recruiting |
| Brescia, Italy, 25123 | |
| Contact: Alessandro Re, MD +39030399 ext 5438 sandrore@aruba.it | |
| Principal Investigator: Giuseppe Rossi, MD | |
| 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 February 21, 2013
