Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma
Peripheral T-cell Lymphoma
About this trial
This is an interventional treatment trial for Peripheral T-cell Lymphoma focused on measuring peripheral T-cell lymphomas, bortezomib, ACVBP regimen
Eligibility Criteria
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.
Sites / Locations
- Groupe d'Etude des Lymphomes de l'Adulte
- Service d'Hématologie - Centre Hospitalier Lyon-Sud
- Centre Hospitalier Robert Debré
- Centre Henri Becquerel
- Institut Gustave Roussy
Arms of the Study
Arm 1
Experimental
Experimental
Velcade, Doxorubicine, Cyclophosphamide, Vindesine, Bleomycin, Prednisone