Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma
NCT ID: NCT00136565
Last Updated: 2018-08-23
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
60 participants
INTERVENTIONAL
2006-01-08
2011-04-18
Brief Summary
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Detailed Description
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It is anticipated that 60 subjects will be enrolled over two years (from June 2005 to May 2007).
The duration of the treatment period is approximately 28 weeks and patients are followed until death.
The total duration of the study is expected to be 5 years (from June 2005 to May 2010).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental
Velcade, Doxorubicine, Cyclophosphamide, Vindesine, Bleomycin, Prednisone
Velcade
1.5 mg/m², D1, D5, 4 cycles
Doxorubicin
75 mg/m², D1, 4 cycles
Prednisone
60 mg/m², D1-D5, 4 cycles
Cyclophosphamide
1200 mg/m², D1, 4 cycles
Vindesine
2 mg/m², D1, D5, 4 cycles
Bleomycin
10 mg, D1, D5, 4 cycles
Interventions
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Velcade
1.5 mg/m², D1, D5, 4 cycles
Doxorubicin
75 mg/m², D1, 4 cycles
Prednisone
60 mg/m², D1-D5, 4 cycles
Cyclophosphamide
1200 mg/m², D1, 4 cycles
Vindesine
2 mg/m², D1, D5, 4 cycles
Bleomycin
10 mg, D1, D5, 4 cycles
Eligibility Criteria
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Inclusion Criteria
* Ages 18 to 65 years.
* Life expectancy \> 3 months.
* Written informed consent.
Exclusion Criteria
* Any previous therapy for lymphoma except for short-term corticosteroids before inclusion.
* Inability to tolerate the ACVBP regimen according to investigator's judgement.
* Positive serology for HIV.
* Poor renal function (creatinin \> 150 µmol/l within 14 days before enrollment), poor liver function (total bilirubin \> 30 µmol/l, transaminases \> 2.5 upper normal limit \[UNL\] within 14 days before enrollment), unless these abnormalities are related to the lymphoma.
* Poor bone marrow reserve as defined by neutrophils \< 1.5 G/l or platelets \< 100 G/l within 14 days before enrollment, unless these abnormalities are related to the lymphoma.
* Patient with \>= grade 2 peripheral neuropathy non-related to lymphoma.
* Any central nervous system (CNS) disease.
* CNS or meningeal involvement by the lymphoma.
* Any serious active disease or comorbidity according to the investigator's decision.
* Any history of cancer during the last 5 years with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma.
* Known hypersensitivity to bortezomib, boron or mannitol.
* Contraindication to any cytotoxic drug contained in chemotherapy regimen.
* Pregnant or lactating women or women of childbearing potential not willing to use an adequate method of birth control (i.e. hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of study.
* Men not agreeing to take adequate contraceptive precautions during the study.
* Treatment with investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
* Adult patient under tutelage.
18 Years
65 Years
ALL
No
Sponsors
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Janssen-Cilag International NV
INDUSTRY
Lymphoma Study Association
OTHER
Responsible Party
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Principal Investigators
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Bertrand Coiffier, MD
Role: STUDY_CHAIR
Hospices Civils de Lyon, Lyon, France
Alain Delmer, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Robert Debré
Locations
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Groupe d'Etude des Lymphomes de l'Adulte
Yvoir, , Belgium
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
Centre Hospitalier Robert Debré
Reims, , France
Centre Henri Becquerel
Rouen, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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Goy A, Younes A, McLaughlin P, Pro B, Romaguera JE, Hagemeister F, Fayad L, Dang NH, Samaniego F, Wang M, Broglio K, Samuels B, Gilles F, Sarris AH, Hart S, Trehu E, Schenkein D, Cabanillas F, Rodriguez AM. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2005 Feb 1;23(4):667-75. doi: 10.1200/JCO.2005.03.108. Epub 2004 Dec 21.
O'Connor OA, Wright J, Moskowitz C, Muzzy J, MacGregor-Cortelli B, Stubblefield M, Straus D, Portlock C, Hamlin P, Choi E, Dumetrescu O, Esseltine D, Trehu E, Adams J, Schenkein D, Zelenetz AD. Phase II clinical experience with the novel proteasome inhibitor bortezomib in patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma. J Clin Oncol. 2005 Feb 1;23(4):676-84. doi: 10.1200/JCO.2005.02.050. Epub 2004 Dec 21.
Orlowski RZ. Proteasome inhibitors in cancer therapy. Methods Mol Biol. 2005;301:339-50. doi: 10.1385/1-59259-895-1:339.
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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Janssen: i061-341-03
Identifier Type: -
Identifier Source: secondary_id
Eudract: 2005-001563-66
Identifier Type: -
Identifier Source: secondary_id
LNH05-1T
Identifier Type: -
Identifier Source: org_study_id
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