A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, MULTI-NATIONAL PHASE III TRIAL TO COMPARE EFFICACY AND SAFETY OF BI 695500 PLUS CHEMOTHERAPY VERSUS RITUXIMAB PLUS CHEMOTHERAPY IN PATIENTS WITH UNTREATED FOLLICULAR NON-HODGKIN´S LYMPHOMA.

Boehringer Ingelheim International GmbH,0 个研究点目标入组 0 人开始时间: 2013年3月21日最近更新: 2023年9月4日

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•1. MUST GIVE WRITTEN INFORMED CONSENT AND BE WILLING TO FOLLOW THIS CTP.
•2. MALE OR FEMALE PATIENTS, AT LEAST 18 YEARS OF AGE AT SCREENING.
•3. UNTREATED, HISTOLOGICALLY CONFIRMED, STAGE III OR IV NHL (CD20+ FL OF GRADE 1, 2 OR 3A, REQUIRING CHEMOTHERAPY).
•4. AVAILABILITY OF TUMOR SAMPLE OBTAINED WITHIN SIX MONTHS OF SCREENING OR FOUR MONTHS IF AN INCREASE IN LDH OR B SYMPTOMS OCCURRED PRIOR TO TRIAL ENTRY
•5. PATIENTS NOT PREVIOUSLY TREATED FOR THEIR FL. THE ONLY EXCEPTION IS PATIENTS PREVIOUSLY TREATED WITH LOCALIZED RADIOTHERAPY, IN WHICH CASE THEY MAY BE ELIGIBLE FOR THE TRIAL. ELIGIBLE PATIENTS PREVIOUSLY ON WATCH AND WAIT (I.E., THOSE PATIENTS WHO DO NOT REQUIRE TREATMENT UPFRONT AT THE TIME OF THE DIAGNOSIS) CAN ENTER THE TRIAL.
•6. ECOG PERFORMANCE STATUS OF 0 TO 2.
•7. HAVE AT LEAST ONE MEASURABLE LESION AS PER THE IWG CRITERIA 2007 AT SCREENING (LESION CLEARLY MEASURABLE IN AT LEAST TWO PERPENDICULAR DIMENSIONS; SEE APPENDIX 10.1 FOR FURTHER DETAILS).
•8. ADEQUATE HEMATOLOGICAL FUNCTION (UNLESS ABNORMALITIES ARE RELATED TO LYMPHOMA INFILTRATION OF THE BONE MARROW) WITHIN 28 DAYS PRIOR TO RANDOMIZATION, INCLUDING:
•HEMOGLOBIN ≥ 9.0 G/DL (≥ 5.6 MMOL/L).
•ABSOLUTE NEUTROPHIL COUNT ≥ 1.5 X 10⁹/L.
•PLATELET COUNT ≥ 100 X 10⁹/L.

•1. TRANSFORMATION TO HIGH-GRADE LYMPHOMA (SECONDARY TO LOW GRADE LYMPHOMA).
•2. PRESENCE OR HISTORY OF CENTRAL NERVOUS SYSTEM (CNS) LYMPHOMA.
•3. PATIENTS RECEIVING CURRENT TREATMENT WITH ORAL CORTICOSTEROIDS MUST NOT BE RECEIVING A DOSE EXCEEDING 20 MG/DAY PREDNISONE OR EQUIVALENT.
•4. PREVIOUS TREATMENT WITH MAXIMUM CUMULATIVE DOSES OF DOXORUBICIN, DAUNORUBICIN, IDARUBICIN AND/OR OTHER ANTHRACYCLINES AND ANTHRACENEDIONES.
•5. PATIENTS WITH PRIOR OR CONCOMITANT MALIGNANCIES WITHIN 5 YEARS PRIOR TO SCREENING EXCEPT NON-MELANOMA SKIN CANCER OR ADEQUATELY TREATED IN SITU CERVICAL CANCER.
•6. MAJOR SURGERY (EXCLUDING LYMPH NODE BIOPSY) WITHIN 28 DAYS PRIOR TO RANDOMIZATION.
•7. POOR RENAL FUNCTION: SERUM CREATININE > 2.0 MG/DL (> 197 MCMOL/L).
•8. POOR HEPATIC FUNCTION: TOTAL BILIRUBIN > 2.0 MG/DL (> 34 MCMOL/L) OR ASPARTATE AMINOTRANSFERASE (AST) > 3 TIMES THE UPPER LIMIT OF NORMAL, UNLESS THESE ABNORMALITIES ARE THOUGHT TO BE RELATED TO HEPATIC INFILTRATION BY FL, GILBERT´S SYNDROME OR HEMOLYSIS.
•9. ACTIVE, CHRONIC OR PERSISTENT INFECTION THAT MIGHT WORSEN WITH IMMUNOSUPPRESSIVE TREATMENT (E.G., HUMAN IMMUNODEFICIENCY VIRUS [HIV], HEPATITIS C VIRUS).

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