A PHASE 3, RANDOMIZED, PARALLEL-GROUP, ACTIVE-CONTROLLED, DOUBLE-BLIND STUDY TO COMPARE THE EFFICACY AND SAFETY OF CT-P10 WITH MABTHERA, EACH ADMINISTERED IN COMBINATION WITH CYCLOPHOSPHAMINE, VINCRISTINE, AND PREDNISONE (CVP) IN PATIENTS WITH ADVANCED FOLLICULAR LYMPHOMA

Celltrion, Inc.,0 个研究点目标入组 0 人开始时间: 2012年1月16日最近更新: 2023年9月4日

试验速览

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•1. PATIENT MALE OR FEMALE BETWEEN 18 AND 75 YEARS, INCLUSIVE.
•2. HISTOLOGY FL HAVE CONFIRMED UNDER THE REVISED European-American LYMPHOMA CLASSIFICATION OF WORLD HEALTH ORGANIZATION (WHO) GRADES 1 TO 3 ON THE BASIS OF REVISION OF THE CENTRAL LABORATORY.
•3. HAVE AT LEAST ONE MEASURABLE TUMOR MASS (CM 1.5 OVER THE LONGEST DIMENSION O 1.1 1.5 CM ON LONGER AND HIGHER DIMENSION OF 1.0 CM IN SHORTER SHAFT) NOT HAS BEEN PREVIOUSLY IRRADIATED.
•4. CD20 + LYMPHOMA HAVE CONFIRMED AS ASSESSED THE CENTRAL LABORATORY REVISION. (TISSUE OBTAINED WITHIN 6 MONTHS PRIOR TO DAY 1 OF CYCLE 1 BE REVIEWED BY A CENTRAL INDEPENDENT AUDITOR TO IDENTIFY THE PATHOLOGICAL TYPE).
•5. HAVE LYMPHOMA STAGE III OR IV CLASSIFICATION BY ANN ARBOR.
•6. OR HAVE A SCORE OF 2 IN THE LEVEL OF ACTIVITY BY COOPERATIVE ONCOLOGY GROUP EAST (ECOG).
•7. HAVE A LIFE EXPECTANCY OF MORE THAN 6 MONTHS.
•8. FL NEED FOR TREATMENT BY PARTICIPANT CLINICAL MEDICAL OPINION.

•1. HAVE ALLERGIES OR HYPERSENSITIVITY TO MURINE PROTEINS, CHIMERIC OR HUMANIZED HUMAN, CYCLOPHOSPHAMIDE, VINCRISTINE OR PREDNISONE.
•2. HAVE EVIDENCE OF TRANSFORMATION HISTOLOGIC A BIG B lymphocytes LYMPHOMA IN HIGH OR DIFFUSE.
•3. COMMITMENT TO HAVE KNOWN OF THE CENTRAL NERVOUS SYSTEM.
•4. PRETREATMENT RECEIPT FOR THE NHL.
•5. RECENT RADIATION OR HAVE HAD SURGERY WITHIN 4 WEEKS PRIOR TO DAY 1 OF CYCLE 1 EXCEPT FOR A BIOPSY OF LYMPH NODES.
•6. HAVE A CURRENT DIAGNOSIS OF TUBERCULOSIS (TB) DEFINED BY THORACIC RADIOGRAPHY OR OTHER SERIOUS INFECTIONS AS SEPSIS, ABSCESSES O OPPORTUNISTIC INFECTIONS.
•7. HAVE KNOWN INFECTION BY HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION WITH HEPATITIS C HEPATITIS BO (NOT ALLOWED TO HEPATITIS B CARRIERS IN THE STUDY ENLIST).
•8. HEART FAILURE TO HAVE CLASS III OR IV CLASSIFICATION BY HEART ASSOCIATION OF NEW YORK [HEAR NEW YORK ASSOCIATION, NYHA] UNCONTROLLED A SERIOUS HEART (UNSTABLE ANGINA, ARRHYTHMIA, SIGNIFICANT PROBLEMS FROM THE PERSPECTIVE OF CLINICAL IN EKG [ECG]) OR HEART ATTACK IN THE 6 MONTHS PRIOR TO THE DATE OF APPROVAL.

发起方

Celltrion, Inc.,