None listed
Conditions
Interventions
INCLUDE STUDY CENTERS IN EUROPE, AFRICA, MIDDLE EAST, ASIA-PACIFIC AND LATIN AMERICA.
APPROXIMATELY 740 FL PATIENTS WITH STAGE III-IV FL will be randomized 1:1 RATIO IN A RECEIVING CT-P1O (370 PATI
Sponsors
Celltrion, Inc.,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Countries
Korea South
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed