A RANDOMIZED, CONTROLLED, DOUBLE-BLIND PHASE III TRIAL TO COMPARE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF GP2013 VS. MABTHERA® PLUS CVP, FOLLOWED BY GP2013 OR MABTHERA ® MAINTENANCE THERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED, ADVANCED STAGE FOLLICULAR LYMPHOMA

Not Applicable

• Registration Number: PER-082-11
• Lead Sponsor: Hexal AG,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-16
• Study Completion: 2017-08-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 11

Inclusion Criteria

1. PATIENT WITH PREVIOUSLY UNTREATED ADVANCED STAGE, CD20-POSITIVE FL:
A. ANN ARBOR CLASSIFICATION STAGE III/IV; AND
B. WHO HISTOLOGIC GRADE 1, 2 OR 3A, AS CONFIRMED BY CENTRAL PATHOLOGICAL TESTING.
2. PATIENT AGE ≥ 18 YEARS.
3. PATIENT WITH AT LEAST ONE MEASURABLE LESION (ACCURATELY MEASURABLE IN AT LEAST 2 PERPENDICULAR DIMENSIONS);
A. AT LEAST 1 MEASURABLE NODAL LESION > 20 MM IN THE LONG AXIS; OR
B. AT LEAST MEASURABLE EXTRANODAL LESION WITH BOTH LONG AND SHORT AXES ≥ 10 mm.
4. PATIENT WITH ECOG PERFORMANCE STATUS 0, 1 OR 2.
5. PATIENT WITH ADEQUATE CARDIAC FUNCTION DEFINED AS CARDIAC EJECTION FRACTION ≥ 45% AS MEASURED BY 2D-ECHO OR MUGA, WITHOUT CLINICALLY SIGNIFICANT ABNORMALITIES.
6. PATIENT WITH THE FOLLOWING LABORATORY VALUES OTAINED DURING SCREENING (UP TO 21 DAYS BEFORE RANDOMIZATION):
A. HEMOGLOBIN ≥ 10 g/dL (UNLESS ABNORMALITIE ARE DUE TO HISTOLOGICALLY PROVEN BONE MARROW INVOLVEMENT BY LYMPHOMA);

Exclusion Criteria

1. PATIENT WITH GRADE 3B (AGGRESSIVE) FL OR ANY HISTOLOGY OTHER THAN L GRADE 1, 2 OR 3A.
2. PATIENT WITH HISTOLOGICAL EVIDENCE OF TRANSFORMATION TO HIGH GRADE OR DIFUSSE LARGE B-CELL LYMPHOMA.
3. PATIENT WHO HAS PREVIOUSLY RECEIVED ANY PRIOR THERAPY FOR LYMPHOMA (e.g. CYTOSTATIC OR CYTOTOXIC AGENTS, RADIOTHERAPY, ANTIBODIES, ANTI-LYMPHOMA VACCINATION, EXPERIMENTAL TREATMENTS)
4. EVIDENCE OF SIGNIFICANT LEUKEMIC DISEASE.
5. PATIENT WITH EVIDENCE OF CENTRAL NERVOUS SYSTEM (CNS) INVOLVEMENT BY LYMPHOMA OR ANY EVIDENCE OF SPINAL CORD COMPRESSION BY LYMPHOMA.
6. PATIENT WITH EVIDENCE OF ANY UNCONTROLLED, ACTIVE INFECTION (VIRAL, BACTERIAL OR FUNGAL).
7. PATIENT RECEIVING CHRONIC DOSES OF CORTICOSTEROIDS ( > 20 MG OF PREDNISONE OR > APPROXIMATELY 3 MG OF DEXAMETHASONE PER DAY; OR EQUIVALENT DOSES OF OTHER STEROID MEDICATIONS).
8. PATIENT WITH ANY MALIGNANCY WITHIN 5 YEARS PRIOR TO DATE OF RANDOMIZATION, WITH THE EXCEPTION OF ADEQUATELY TREATED IN SITU CARCINOMA OF THE CERVIX UTERI, BASAL OR SQUAMOUS CELL CARCINOMA OR NON-MELANOMATOUS SKIN CANCER.

Study & Design

• Study Type: Interventional
• Study Design: Not specified