Clinical trial NCT00136565 (phase 2, status: completed)
Conditions: peripheral t-cell lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: velcade, doxorubicin, prednisone, cyclophosphamide, vindesine, bleomycin
SMILES: CN1C(CCCC(O)=O)=NC2=CC(=CC=C12)N(CCCl)CCCl, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C, ClCCN(CCCl)P1(=O)NCCCO1, [H][C@@]12N3CC[C@@]11C4=C(C=C(OC)C(=C4)[C@]4(C[C@@H]5C[N@@](C[C@](O)(CC)C5)CCC5=C4NC4=CC=CC=C54)C(=O)OC)N(C)[C@@]1([H])[C@](O)([C@H](O)[C@]2(CC)C=CC3)C(N)=O, C[C@@H](O)[C@H](NC(=O)[C@@H](C)[C@H](O)[C@@H](C)NC(=O)[C@@H](NC(=O)C1=C(C)C(N)=NC(=N1)[C@H](CC(N)=O)NC[C@H](N)C(N)=O)[C@@H](OC1OC(CO)C(O)C(O)C1OC1OC(CO)C(O)C(OC(N)=O)C1O)C1=CN=CN1)C(=O)NCCC1=NC(=CS1)C1=NC(=CS1)C(=O)NCCC[S+](C)C
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.