A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE III STUDY OF RAD001 ADJUVANT THERAPY IN POOR RISK PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) OF RAD001 VERSUS MATCHING PLACEBO AFTER PATIENTS HAVE ACHIEVED COMPLETE RESPONSE WITH FIRST-LINE RITUXIMAB-CHEMOTHERAPY

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2011年11月24日最近更新: 2023年9月4日

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•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.

•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.

发起方

OVARTIS BIOSCIENSES PERU S.A.,