None listed
Conditions
Interventions
AS PART OF THE SAFETY MONITORING, AN EARLY SAFETY ANALYSIS IS PLANNED WHEN APPROXIMATELY 200 PATIENTS HAVE BEEN TREATED WITH AT LEAST ONE CYCLE AND HAVE AT LEAST ONE POST-BASELINE SAFETY ASSESSMENT.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. PATIENTS WITH PREVIOUS HISTOLOGICALLY-CONFINNED STAGE III-IV (OR STAGE II BULKY DISEASE DEFINED AS ANY TUMOR MASS MORE THAN 10 CM IN LARGEST DIAMETER), AT TIME OF ORIGINAL DIAGNOSIS, DIFFUSE LARGE B CELL LYMPHOMA (PATHOLOGY REPORT BASED ON ORIGINAL TUMOR TISSUE/LYMPH NODE IS ACCEPTABLE FOR MEETING INCLUSION CRITERIA, BUT TUMOR TISSUE (SLIDES/BLOCK) MUST BE AVAILABLE TO BE SENT FOR CENTRAL PATHOLOGY TO CONFIRM DIAGNOSIS). 2. PATIENTS DEFINED AS•POOR RISK WITH IPI OF 3,4, OR 5 AT TIME OF ORIGINAL DIAGNOSIS. 3. PATIENTS AGE ≥ 18 YEARS OLD. 4. PATIENTS MUST HAVE ACHIEVED COMPLETE REMISSION (CR) BASED ON THE REVISED IWRC (CHESON ET AL 2007) FOLLOWING FIRST TINE R-CHEMOTHERAPY TREATMENT. RADIATION THERAPY TARGETED ONLY AT BULKY OR LARGE TUMOR MASS DURING OR AFTER R-CHEMOTHERAPY IS ACCEPTABLE IF THE RADIATION THERAPY ENDED 4 WEEKS PRIOR TO START OF STUDY DRUG. COMPLETE REMISSION FROM R-CHEMOTHERAPY MUST BE CONFIRMED BY CLINICAL AND RADIOLOGIC EVALUATION ALONG WITH BONE MARROW CONFIRMATION (IF BONE MARROW WAS INVOLVED BY LYMPHOMA BEFORE THE R-CHEMOTHERAPY TREATMENT).
Exclusion criteria
Exclusion criteria: 1. PATIENTS WITH EVIDENCE OF DISEASE ACCORDING TO THE REVISED IWRC (CHESON ET AL 2007) AFTER COMPLETION OF THE FIRST-LINE R-CHEMOTHERAPY TREATMENT, PRIOR TO STUDY ENTRY. 2. PATIENTS RECEIVING ONGOING RADIATION THERAPY OR WHO RECEIVED RADIATION THERAPY TO THE RESIDUAL TUMOR MASSES < 4 WEEKS FROM START OF STUDY DRUG. 3. PATIENTS WHO HAVE PREVIOUSLY RECEIVED SYSTEMIC MTOR INHIBITOR (SIROLIMUS, TEMSIROLIMUS, EVEROLIMUS, ETC). 4. PATIENTS WITH EVIDENCE OF CURRENT CENTRAL NERVOUS SYSTEM (CNS) INVOLVEMENT WITH LYMPHOMA. PATIENTS WHO HAVE ONLY HAD PROPHYLACTIC INTRATHECAL OR INTRAVENOUS CHEMOTHERAPY AGAINST CNS DISEASE ARE ELIGIBLE. 5. PATIENTS WITH TRANSFORMED FOLLICULAR LYMPHOMA. 6. PATIENTS WHO RECEIVED IBRITUMOMAB TIUXETAN (ZEVALIN, IN ORDER, TO AVOID POTENTIAL DELAYED KIDNEY TOXICITIES. 7. PATIENTS WHO HAD MYELOSUPPRESSIVE CHEMOTHERAPY OR BIOLOGIC THERAPY < 3 WEEKS FROM START OF STUDY DRUG. 8. PATIENTS RECEIVING CHRONIC SYSTEMIC IMMUNOSUPPRESSIVE AGENTS. INHALED AND TOPICAL STEROIDS ARE ACCEPTABLE. PATIENTS MAY BE RECEIVING STABLE (NOT INCREASED WITHIN THE LAST MONTH) CHRONIC DOSES OF CORTICOSTEROIDS WITH A MAXIMUM DOSE OF 20 MG OF PREDNISONE OR ≤ 5 MG OF DEXAMETHASONE PER DAY, IF THEY ARE BEING GIVEN FOR DISORDERS OTHER THAN LYMPHOMA SUCH AS RHEUMATOID ARTHRITIS, POLYMYALGIA RHEUMATICA OR ADRENAL INSUFFICIENCY OR ASTHMA.
Countries
Arabia Saudi, Argentina, Australia, Austria, Brazil, Canada, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea North, Lebano, Mexico, New Zealand, Norway, Poland, Russian Federation, Singapore, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, United States, Venezuela
Contacts
Public ContactJuan Reyes
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed