- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01045889
High Dose Therapy and Peripheral Blood Stem Cell Transplantation in HIV Related Non Hodgkin Lymphoma (NHL) at High Risk (HDT-HIV)
August 18, 2016 updated by: Giuseppe Rossi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brescia, Italy, 25123
- AO Spedali Civili di Brescia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 2-years
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2-years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Partial and complete responses
Time Frame: Evaluation of response one month after peripheral blood transplantation
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Evaluation of response one month after peripheral blood transplantation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Giuseppe Rossi, MD, Haematology Division - AO Spedali Civili di Brescia - Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (ACTUAL)
May 1, 2016
Study Completion (ACTUAL)
May 1, 2016
Study Registration Dates
First Submitted
January 8, 2010
First Submitted That Met QC Criteria
January 8, 2010
First Posted (ESTIMATE)
January 11, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
August 19, 2016
Last Update Submitted That Met QC Criteria
August 18, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, B-Cell
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, AIDS-Related
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Cyclophosphamide
- Etoposide
- Rituximab
- Prednisone
- Melphalan
- Vincristine
Other Study ID Numbers
- ema2_LNH e HIV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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