None listed
Conditions
Interventions
SELECTION ASSESSMENT IS CARRIED OUT IN 8 WEEKS PRIOR TO THE FIRST STUDY DRUG DOSE (-55 DAY TO DAY 0). SEE TABLE 7-1 FOR DETAILS OF SELECTION PROCEDURES. IT IS REQUIRED A CENTRAL REVIEW OF TUMOR TISSUE
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 CONFIRMED STAGE III-IV FOR STAGE II BULKY DISEASE, DEFINED AS ANY TUMOR MASS MORE THAN 10 cm IN LONGEST DIAMETER), AT TIME OF ORIGINAL DIAGNOSIS, DIFFUSE LARGE B CELL LYMPHOMA (PATHOLOGY REPORT BASE 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 WEEK IPI OF 3, 4, OR 5 AT TIME OF ORIGINAL DIAGNOSIS. 3. PATIENTS AGE ≥ 18 YEARS OLD. 4. PATIENTS MUST HAVE ACHIVIED COMPLETE REMISSION (CR) BASED ON THE REVISED IWRC (CHESON ET AT 2007) FOLLOWING FIRST-LINE R-CHOP TREATMENT. RADIATION THERAPY IN COMBINATION WITH R-CHOP IS ACCEPTABLE IF THE RADIATION THERAPY ENDED BY THE TIME OF R-CHOP COMPLETION. COMPLETE REMISSION FROM R-CHOP MUST BE CONFIRMED BY CLINICAL AND RADIOLOGIC EVALUATION ALONG WITH BONE MARROW CONFIRMATION (IF BONE MARROW WAS INVOLVED BY LYMPHOMA BEFORE THE R-CHOP TREATMENT). LOCAL PATHOLOGY REPORT ON THE BONE MARROW BIOPSY IS ACCEPTABLE. IF BONE MARROW WAS NOT INVOLVED BY LYMPHOMA BEFORE R-CHOP TREATMENT, THEN ANOTHER BONE MARROW CONFIRMATION AFTER R-CHOP IS NOT REQUIRED.
Exclusion criteria
Exclusion criteria: 1. PATIENTS WITH EVIDENCE OF DISEASE ACCORDING TO THE REVISED IWRC (CHESON ET AT 2007) AFTER COMPLETION OF THE FIRST-LINE R-CHOP TREATMENT, PRIOR TO STUDY ENTRY. 2. PATIENTS RECEIVING ONGOING RADIATION THERAPY OR WHO RECEIVED RADIATION ..... TO THE TUMOR MASSES AFTER COMPLETING R-CHOP. 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 TRANSFORMED FOLLICULAR LYMPHOMA. 6. PATIENTS WHO RECEIVED IBRITUMOMAB, TIUXETAN (ZEVALIN ®), IN ORDEN 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 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