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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01045889 |
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Date of registration:
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08/01/2010 |
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Primary sponsor: |
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Public title:
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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 |
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Scientific title:
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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 |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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43 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01045889 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Contacts
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Name:
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Alessandro Re, MD |
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Address:
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Telephone:
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+39030399 |
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Email:
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sandrore@aruba.it |
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Affiliation:
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Name:
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Giuseppe Rossi, MD |
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Address:
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Telephone:
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+39 030 399 |
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Email:
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rossig@med.unibs.it |
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Affiliation:
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Name:
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Giuseppe Rossi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Haematology Division - AO Spedali Civili di Brescia - Italy |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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HIV-related Lymphoma
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Intervention(s)
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Other: Rituximab and CHOP regimen + PBSCT
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Primary Outcome(s)
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Overall survival
[Time Frame: 6 months]
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Secondary Outcome(s)
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Partial and complete responses
[Time Frame: Evaluation of response one month after peripheral blood transplantation]
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Secondary ID(s)
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ema2_LNH e HIV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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