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Main
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Note: This record shows only 22 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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12 December 2020 |
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Main ID: |
NCT00136565 |
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Date of registration:
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26/08/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma
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Scientific title:
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A Phase II Study Evaluating the Efficacy and Safety of Bortezomib (Velcade™) Combined With ACVBP Regimen in Patients With Previously Untreated Peripheral T-cell Lymphoma |
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Date of first enrolment:
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January 8, 2006 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00136565 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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France
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Contacts
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Name:
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Alain Delmer, 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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Centre Hospitalier Robert Debré |
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Name:
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Bertrand Coiffier, 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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Hospices Civils de Lyon, Lyon, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Previously untreated non-cutaneous peripheral T-cell lymphoma, including human T-cell
lymphotropic virus type 1 (HTLV-1) related T-cell lymphoma, and natural killer
(NK)-cell lymphoma.
- Ages 18 to 65 years.
- Life expectancy > 3 months.
- Written informed consent.
Exclusion Criteria:
- B-cell lymphoma or other subtype of T-cell lymphoma including anaplastic large cell
lymphoma AKL(+), lymphoblastic lymphoma and primary cutaneous T-cell lymphoma.
- 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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Peripheral T-cell Lymphoma
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Intervention(s)
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Drug: Doxorubicin
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Drug: Bleomycin
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Drug: Cyclophosphamide
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Drug: Velcade
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Drug: Vindesine
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Drug: Prednisone
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Primary Outcome(s)
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Event-free survival (EFS)
[Time Frame: 2 years]
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Secondary Outcome(s)
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Complete response rate unconfirmed (CR+CR uncertain)
[Time Frame: 2 years]
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Partial response (PR) rate
[Time Frame: 2 years]
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Duration of response in complete responders (CR + CRu)
[Time Frame: 2 years]
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Number of SAE
[Time Frame: 2 years]
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Progression free survival (PFS)
[Time Frame: 2 years]
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Overall survival (OS)
[Time Frame: 2 years]
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Secondary ID(s)
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Eudract: 2005-001563-66
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Janssen: i061-341-03
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LNH05-1T
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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