Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma

• Status: Completed
• Trial end date: 2011-04-18
• Target enrollment: 0
• Participant gender: All

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, cyclophosphamide, vindesine, bleomycin, and prednisone]) in the treatment of previously untreated patients with peripheral T-cell lymphoma (PTCL).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lymphoma Study Association
• Collaborator: Janssen-Cilag International NV
• Treatments: Bleomycin; Bortezomib; Cyclophosphamide; Doxorubicin; Prednisone; Vindesine

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.