Clinical trial NCT00428142 (phase 2, status: completed)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: bortezomib, cyclophosphamide, prednisone, vincristine sulfate
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1, [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, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed follicular non-Hodgkin's lymphoma meeting the following
             criteria:

               -  Stage III or IV disease

               -  Grade 1, 2, or 3 disease requiring systemic first-line treatment

               -  No transformation to diffuse large cell lymphoma

          -  At least 1 bidimensionally measurable lesion meeting 1 of the following criteria:

               -  Lymph nodes > 1.5 cm x 1.0 cm by physical exam or CT scan

               -  Other non-nodal lesion ≥ 1.0 cm x 1.0 cm by MRI or CT scan OR ≥ 1.0 cm x 1.0 cm
                  (e.g., skin lesions or nodules) by physical exam

          -  Must have a medical indication for treatment, as indicated by 1 of the following:

               -  Presence of constitutional symptoms that are attributed to lymphoma (e.g., B
                  symptoms, including night sweats, fever, weight loss, fatigue, or pain)

               -  Lymphadenopathy that requires treatment based on presence of associated symptoms,
                  potential threat to organ function (e.g., ureteric compromise from
                  retroperitoneal disease), or degree of enlargement (i.e., > 5 cm)

               -  Impairment of normal organ function (e.g., impaired hematopoiesis due to marrow
                  involvement by lymphoma or from splenomegaly and hypersplenism)

               -  Immune-related complications of lymphoma that require therapy

               -  Rate of disease progression for which observation is deemed inappropriate

          -  No history of any other lymphoproliferative disorder or evidence of transformation to
             an aggressive histology lymphoma

          -  No known CNS involvement by lymphoma

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 12 weeks

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Platelet count ≥ 75,000/mm^3*

          -  Absolute neutrophil count ≥ 1,000/mm^3*

          -  Creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  Bilirubin ≤ 1.5 times ULN

          -  AST or ALT ≤ 2.5 times ULN (5 times ULN if liver involvement with lymphoma)

          -  Able (i.e., sufficiently fluent) and willing to complete the quality of life
             questionnaires in either English or French

               -  Inability (illiteracy in English or French, loss of sight, or other equivalent
                  reason) to complete the questionnaires will not make the patient ineligible for
                  the study

          -  No history of other malignancies, except for the following:

               -  Adequately treated nonmelanoma skin cancer

               -  Curatively treated in situ cancer of the cervix

               -  Ductal carcinoma in situ of the breast (as long as radiation limitation is not
                  exceeded)

               -  Other solid tumors curatively treated with no evidence of disease for > 5 years

          -  No history of allergic reactions attributed to compounds containing boron or mannitol

          -  No history of an unusual or severe allergic reaction to rituximab or similar agent

          -  No pre-existing neuropathy ≥ grade 2

          -  No known HIV infection

          -  No other serious illness or medical condition that would preclude study participation,
             including any of the following:

               -  Active, uncontrolled bacterial, fungal, or viral infection

               -  Significant cardiac dysfunction

               -  Cardiovascular disease NOTE: *Exceptions will be allowed for values below these
                  thresholds in patients with marrow involvement by lymphoma or lymphoma-related
                  hypersplenism

        PRIOR CONCURRENT THERAPY:

          -  No prior systemic therapy for lymphoma

          -  No prior bortezomib, cyclophosphamide, or vincristine

          -  At least 4 weeks since prior radiotherapy that involved ≤ 25% of functioning bone
             marrow and recovered

               -  Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy or if the
                  irradiated field is not a significant marrow-bearing area

          -  At least 2 weeks since prior major surgery

          -  No other concurrent anticancer therapy, investigational agents, corticosteroids
             (except for physiologic replacement or antiemesis), cytotoxic chemotherapy, or
             immunotherapy