ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma
NCT ID: NCT00169130
Last Updated: 2007-07-13
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/PHASE3
300 participants
INTERVENTIONAL
1999-10-31
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
Interventions
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doxorubicin
cyclophosphamide
Autologous stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 60 years
* Non previously treated
* With one and only one of the following adverse characteristics: ECOG performance status 2 or more, or Ann Arbor stage III or IV, or elevated LDH level
* Negative HIV, HBV and HCV serologies (except vaccination)
* With a minimum life expectancy of 3 months
* Having previously signed a written informed consent
Exclusion Criteria
* T-cell lymphoma.
* Central nervous system or meningeal involvement by lymphoma.
* Any Contra-indication to any drug contained in the chemotherapy regimens.
* Poor renal function (creatinin level\>150µmol/l), poor hepatic function (total bilirubin level\>30mmol/l, transaminases\>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
* Serious active disease (according to the investigator's decision).
* Poor bone marrow reserve as defined by neutrophils \<1.5G/l or platelets\<100G/l, unless related to bone marrow infiltration.
* Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
* Childbearing woman.
* Patients previously treated with an organ transplantation.
18 Years
60 Years
ALL
No
Sponsors
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Fondation ARC
OTHER
Lymphoma Study Association
OTHER
Principal Investigators
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Pierre Morel, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Schaffner, Lens FRANCE
Locations
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Service d'Hematologie
Mont-Godinne, , Belgium
Hôpital Henri Mondor
Créteil, , France
Hôpital Saint Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Henri Becquerel
Rouen, , France
Countries
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Related Links
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Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In French)
Other Identifiers
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LNH98-B2
Identifier Type: -
Identifier Source: org_study_id