Status:
COMPLETED
Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma
Lead Sponsor:
Lymphoma Study Association
Collaborating Sponsors:
Janssen-Cilag International NV
Conditions:
Peripheral T-cell Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the efficacy and the safety profile and toxicity of a combination of Velcade™ (bortezomib) with a standard chemotherapy regimen (ACVBP \[doxorubicin, cyclopho...
Detailed Description
This is a multicentric, open-label, non-randomized, non-competitive clinical study, evaluating the efficacy and safety of V-ACVBP chemotherapy in previously untreated patients aged from 18 to 65 years...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00136565
Start Date
January 8 2006
End Date
April 18 2011
Last Update
August 23 2018
Active Locations (5)
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1
Groupe d'Etude des Lymphomes de l'Adulte
Yvoir, Belgium
2
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France, 69495
3
Centre Hospitalier Robert Debré
Reims, France, 51092
4
Centre Henri Becquerel
Rouen, France, 76038