A PHASE II MULTICENTER NON-RANDOMIZED STUDY TO ASSESS SAFETY, TOXICITY AND CLINICAL ACTIVITY OF THE ASSOCIATION OF BORTEZOMID VELCADE WITH RITUXIMAB IN RELAPSED/REFRACTORY INDOLENT NON FOLLICULAR AND MANTLE-CELL NON HODGKIN LYMPHOMA - ND
- Conditions
- relapsed non follicular non-Hodgkin s LymphomaMedDRA version: 6.1Level: HLTClassification code 10029621
- Registration Number
- EUCTR2006-003657-24-IT
- Lead Sponsor
- GIMURE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
1. Patients with na ve 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 Attachment 2 WHO classification of Lymphoma 61623; Small lymphocytic/lymphoplasmocytic lymphoma; 61623; Nodal marginal zone Lymphoma MALT lymphoma are excluded 61623; Splenic marginal zone lymphoma 61623; Mantle cell lymphoma A lympnode biopsy is advisable if it is not harmful for the patients, before enrollement 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. Na ve 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 PLTs 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 8805;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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Potential patients who meet any of the following criteria will be excluded from participating in the study 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. Neuropathy 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate a statistical benefit in overall response rate ORR of the Bortezomid/Rituximab association in relapsed /refractory indolent non-follicular and mantle cell non-Hodgkin lymphoma patients that was na ve or sensitive to rituximab;Secondary Objective: 1 To evaluate the Complete Response CR rate of relapsed /refractory indolent non-follicular and mantle cell non-Hodgkin lymphoma patients treated with the Bortezomid/Rituximab association 2 To evaluate the efficacy of the Bortezomid/Rituximab association to prolong 2-year failure-free survival FFS rate compared to historical standard treatment 3 To assess the safety of Bortezomid/Rituximab association in relapsed/refractory indolent non follicular and mantle cell non Hodgkin lymphoma patients 4 To evaluate overall survival of the patients treated with Bortezomid/Rituximab association;Primary end point(s): Overall Response Rate ORR Complete Remission, Complete Remission Unconfirmed, Partial Remission.
- Secondary Outcome Measures
Name Time Method