Clinical trial NCT00509379 (phase 2, status: completed)
Conditions: lymphoma, non-hodgkin lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: rituximab, velcade
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, CN1C(CCCC(O)=O)=NC2=CC(=CC=C12)N(CCCl)CCCl
Eligibility criteria:

        Inclusion Criteria:

          1. Patients with naïve or sensitive rituximab indolent non-follicular and mantle cell
             non-Hodgkin's Lymphoma disease that had failed to respond or relapsed after primary
             therapy. There is a demonstrated progressive disease requiring further treatment.
             Histological subtype included into the study are are as follows Small
             lymphocytic/lymphoplasmocytic lymphoma; Nodal marginal zone Lymphoma (MALT lymphoma
             are excluded) Splenic marginal zone lymphoma Mantle cell lymphoma A lymphnode biopsy
             is advisable if it is not harmful for the patients, before enrollment of the patient
             into the study in order to confirm diagnosis and to rule out histologic
             transformation. Lymphnode biopsy should be performed within 6 months before study
             entry.

          2. Age >18-75

          3. Relapse or failure to respond after one or more (maximum three) lines of chemotherapy

          4. Any type of prior chemotherapy, rituximab included. Patients who had received high
             dose chemotherapy and ASCT can be enrolled into the study

          5. Naïve or sensitive rituximab disease. If the patient received Rituximab, he/she must
             have responded and the TTP from the last dose to rituximab must have been 6 months or
             more.

          6. Measurable and/or evaluable disease.

          7. Adequate haematological counts: ANC> 1.0 x 109/L and PLT counts> 75 x 109/L unless due
             to bone marrow involvement by lymphoma.

          8. Conjugated bilirubin up to 2 x ULN.

          9. Alkaline phosphatase and transaminases up to 2 x ULN.

         10. Creatinine clearances> 30 m/min.

         11. Non peripheral neuropathy or CNS disease.

         12. Life expectancy> 6 months.

         13. Performance status< 2 according to ECOG scale.

         14. Written informed Consent

        Exclusion Criteria:

          1. Has known or suspected hypersensitivity or intolerance to rituximab, boron, mannitol,
             or heparin, if an indwelling catheter is used

          2. History of clinically relevant liver or renal insufficiency; significant cardiac,
             vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic,
             hematologic, psychiatric, or metabolic disturbances

          3. Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable
             dose for at least 3 months before first dose of study drug

          4. Uncontrolled or severe cardiovascular disease including myocardial infarction within 6
             months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure
             (Attachment 5, NYHA Classification of Cardiac Disease), uncontrolled angina,
             clinically significant pericardial disease, or cardiac amyloidosis

          5. History of hypotension or has decreased blood pressure (sitting systolic blood
             pressure SBP 100 mmHg and/or sitting diastolic blood pressure DBP 60 mmHg)

          6. Pregnant or breastfeeding

          7. Peripheral Neuropathy or Neuropathic Pain Grade 2

          8. HIV positivity

          9. HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with
             HBV-DNA negative

         10. HCV positivity with the exception of patients with no signs of active chronic
             hepatitis histologically confirmed

         11. Active opportunistic infection

         12. Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic
             therapy within 4 weeks before enrollment

         13. Exposure to Rituximab within 24 weeks before screening

         14. Have received an experimental drug or used an experimental medical device within 4
             weeks before the planned start of treatment. Concurrent participation in non-treatment
             studies is allowed, if it will not interfere with participation in this study.

         15. Any other co-existing medical or psychological condition that would preclude
             participation in the study or compromise ability to give informed consent