High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma
NCT ID: NCT00965289
Last Updated: 2009-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2002-04-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HDT combined with rituximab before ASCT
The study treatment consisted on 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.
Rituximab
Rituximab infusion on day 1 dose: 375mg/m²
Interventions
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Rituximab
Rituximab infusion on day 1 dose: 375mg/m²
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aggressive Large B-Cell Lymphoma (CD20+)
* Ann Arbor stage III, IV
* IH or high adjusted IPI
* signed inform consent
Exclusion Criteria
* other type of lymphoma
* serology VIH +
* other neoplasms apart from basal cell carcinoma or situ carcinoma
18 Years
60 Years
ALL
No
Sponsors
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French Innovative Leukemia Organisation
OTHER
Hoffmann-La Roche
INDUSTRY
Nantes University Hospital
OTHER
Responsible Party
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NANTES UNIVERSITY HOSPITAL /GOELAMS
Principal Investigators
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Noel MILPIED, PD MS
Role: PRINCIPAL_INVESTIGATOR
CHU NANTES/GOELAMS
Locations
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University Hospital
Nantes, , France
Countries
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Other Identifiers
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GOELAMS 074
Identifier Type: -
Identifier Source: org_study_id
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