Clinical trial · Interventional
High Dose Therapy and Peripheral Blood Stem Cell Transplantation in HIV Related Non Hodgkin Lymphoma (NHL) at High Risk
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infections | — | UNRESOLVED | — |
| HIV-related Lymphoma | AIDS-Related Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab and CHOP regimen + PBSCT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-CHOP + PBSCT
- 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
- interventionNames
- Other: Rituximab and CHOP regimen + PBSCT
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 2-years
Secondary outcomes (1)
- measure
- Partial and complete responses
- timeFrame
- Evaluation of response one month after peripheral blood transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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)
References
Publications (1)
- BACKGROUNDRe 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. PMID 19451551