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

Not Applicable

• Registration Number: PER-110-11
• Lead Sponsor: Celltrion, Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-16
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified