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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ClinicalTrials.gov Identifier: NCT01045889 |
Recruitment Status
:
Completed
First Posted
: January 11, 2010
Last Update Posted
: August 19, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV-related Lymphoma HIV Infections | Other: Rituximab and CHOP regimen + PBSCT | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
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 |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | May 2016 |

Arm | Intervention/treatment |
---|---|
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
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Other: Rituximab and CHOP regimen + PBSCT
Other Names:
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- Overall survival [ Time Frame: 2-years ]
- Partial and complete responses [ Time Frame: Evaluation of response one month after peripheral blood transplantation ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045889
Italy | |
AO Spedali Civili di Brescia | |
Brescia, Italy, 25123 |
Principal Investigator: | Giuseppe Rossi, MD | Haematology Division - AO Spedali Civili di Brescia - Italy |
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 |
First Posted: | January 11, 2010 Key Record Dates |
Last Update Posted: | August 19, 2016 |
Last Verified: | August 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 |