Clinical trial: Bortezomib, Combination Chemotherapy, and Rituximab as First-Line Therapy in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's Lymphoma (NCT00428142)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs.  She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications.  On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli.

Patient description (patient's own words): I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB.

Does the patient match the trial criteria? Contradiction