Health Condition 1: C823- Follicular lymphoma grade IIIa
Conditions
Interventions
Intervention1: ABP 798: ABP 798 is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen with an identical amino acid sequence to that of ritu
Sponsors
Amgen Inc
Pharmaceutical Research Associates India Pvt
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed (by lymph node or extranodal region biopsy), Grade 1, 2, or 3a follicular B-cell NHL expressing CD20 within 12 months before randomization 2. Stage 2, 3, or 4 (per Cotswoldâ??s Modification of Ann Arbor Staging System 3. Low tumor burden based on the GELF Criteria a.largest nodal or extranodal mass b. no more than 3 nodal sites with diameter > 3 cm c.no splenomegaly > 16 cm by CT scan and no symptomatic splenomegaly d. no significant pleural or peritoneal serous effusions by CT e.lactate dehydrogenase f. no B symptoms (night sweats, fever [temperature > 38°C], weight loss > 10% in the previous 6 months) 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 with measurable disease (per International Working Group) a. subjects must have a baseline scan (computed tomography [CT]) of the neck (if palpable lymph node > 1.0 cm), chest, abdomen, and pelvis to assess disease burden within 6 weeks before randomization b. subjects must have had a baseline bone marrow biopsy within 12 months before randomization. Previously confirmed positive bone marrow involvement does not need to be repeated for purposes of screening. 5. Blood counts: a.absolute neutrophil count (ANC) >= 1.5 x 109/L (1,500/μL) b. lymphocytes c.platelets >= 100 x 109/L (100,000/μL) d. hemoglobin >= 10.0 g/dL 6. Adequate hepatic function as defined by: a.total bilirubin b. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) c. Subjects with an elevated unconjugated bilirubin will be eligible if hepatic enzymes and function are otherwise within normal limits and there is no evidence of hemolysis. 7. Adequate renal function as defined by creatinine = 50 mL/min calculated by the Cockcroft-Gault method 8. Subjects must sign an IRB-approved informed consent form before any study specific procedures.
Exclusion criteria
Exclusion criteria: 1.Diffuse large cell component and/or Grade 3b follicular NHL 2. History or known presence of central nervous system metastases 3. Palliative radiotherapy within 3 months before randomization 4. Malignancy other than NHL within 5 years (except treated in-situ cervical cancer, or squamous or basal cell carcinoma of the skin) 5. Major surgical procedure within 4 weeks before randomization or planned major surgical procedure during the treatment phase 6. Any of the following in the 6 months before randomization: • clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure [New York Heart Association >= Class III], serious uncontrolled cardiac arrhythmia); peripheral vascular disease, cerebrovascular accident, or transient ischemic attack 7. Medically uncontrolled hypertension or systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg 8. Known active or history of active tuberculosis (TB) 9. Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody at screening 10. Known to be human immunodeficiency virus positive 11. Recent infection requiring a course of systemic anti-infective agents that was completed infection) 12. Other investigational procedures that can impact the study data, results, or patient safety while participating in this study are excluded; participation in observational studies is allowed. 13. Subject is currently enrolled in or has not yet completed at least 30 days or 5 half-lives (whichever is longer) since ending other investigational device or drug study(s), including vaccines, or subject is receiving other investigational agent(s) 14. Previous use of either commercially available or investigational chemotherapy, biological, or immunological therapy for NHL (including rituximab or biosimilar rituximab, or other anti-CD20 treatments) 15. Systemic corticosteroid use within 3 months before randomization (inhaled are allowable) 16. Live vaccines within 28 days prior to the first dose of IP 17. History of neurologic symptoms suggestive of central nervous system demyelinating Disease 18. Woman of childbearing potential who is pregnant or is breastfeeding 19. Woman of childbearing potential who does not consent to use highly effective methods of birth control (eg, true abstinence, sterilization, birth control pills, Depo Provera injections, or contraceptive implants) during treatment and for an additional 12 months after the last administration of the protocol specified-treatment 20. Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control (eg, true abstinence, vasectomy, or a condom in combination with hormonal birth control or barrier methods used by the woman) during treatment and for an additional 12 months after the last administration of the protocol specified treatment 21. Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products 22. Subject p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Risk difference (RD) of overall response rate (ORR) of efficacy of ABP 798 compared with rituximab.Timepoint: week 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean ratio (GMR) of test (ABP 798)-to-reference (rituximab)Timepoint: Predose and after end of infusion at week 12;Incidence of anti-drug antibodiesTimepoint: Up to Week 28;On study overall survivalTimepoint: Up to Week 28;On study progression-free survivalTimepoint: Up to Week 28;Percent of subjects with complete depletion of CD19 cell count and total Immunoglobin G (IgG) and IgM antibody levelsTimepoint: Baseline to study day 8;Risk difference (RD) of overall response rate (ORR)of efficacy of ABP 798 compared with rituximab.Timepoint: Week 12;Serum concentrations at predose and immediately after the end of infusionTimepoint: week 12;Subject incidence of treatment-emergent AEs and serious adverse events. Clinical significant changes in laboratory values and vital signs will be reported as AEsTimepoint: Up to Week 28 | — |
Countries
Argentina, Australia, Azerbaijan, Bulgaria, Canada, Colombia, Czech Republic, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Republic of Korea, Romania, Russian Federation, Spain, Ukraine, United States of America
Contacts
Public ContactJigar Lakhani
Pharmaceutical Research Associates India Pvt. Ltd
Outcome results
None listed