None listed
Conditions
Interventions
A TOTAL OF 618 PATIENTS WITH PREVIOUSLY UNTREATED, ADVANCED STAGE (ANN ARBOR STAGE III/IV), FL WITH A WHO HISTOLOGICAL GRADE OF 1-3a WILL BE RANDOMIZED IN A 1:1 RATIO TO RECEIVE EITHER GP2013 WITH CVP
Sponsors
Hexal AG,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Countries
Brazil, Israel, Malasya
Contacts
Public ContactAndres Cesar Martin Bayona
PPD Peru S.A.C.
Outcome results
None listed