None listed
Conditions
Interventions
Test Formulation, Dose, and Regimen: CT P10 (375 mg/m2 intravenous [IV])
Reference Drug, Dose, and Regimen: US-licensed Rituxan (375 mg/m2 IV)
Patients will be assigned in 1:1 ratio to receive C
Sponsors
CELLTRION, INC.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Each patient must meet all of the following criteria to be enrolled in this study: 1)Age ≥18 years.2)Histologically confirmed CD20+ FL grade 1 to 3a according to the World Health Organization 2008 classification.3)Has at least 1 measurable tumour mass in 2 dimensions:a)Nodal lesion >15 mm in the longest dimension; or b)Nodal lesion >10 mm to ≤15 mm in the longest dimension and >10 mm in the shortest dimension; or c) Extranodal lesion with both long and short dimensions ≥10 mm. 4)Ann Arbor stage II, III, or IV disease.5)Low tumour burden, defined as based on Groupe d´Etudes des Lymphomes Folliculaires (GELF) criteria.6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.7)Male and female patients and their partners of childbearing potential, patient agrees to practice total abstinence or to use one of the following medically acceptable methods of contraception during the course of the study and for 12 months following discontinuation of study drug.8) Adequate bone marrow, hepatic, and renal function reserve as evidenced by:a)Hb ≥10 g/dL, b)Absolute neutrophil ≥1500/mm3,c)Platelet ≥100 000/mm3,d)Total bilirubin ≤2.0 mg/dL, e)Aspartate aminotransferase and alanine aminotransferase ≤3 times the upper limit of normal (ULN) for the reference laboratory (≤5 × ULN for the reference laboratory with known hepatic involvement by lymphoma), f)Serum creatinine ≤1.5 × ULN for the reference laboratory, or a calculated creatinine clearance by the Cockcroft-Gault equation of ≥50 mL/min.9)Patient is able to understand instructions and comply with all study requirements.10)Patient is informed, given ample time and opportunity to read and/or understand about participation in the study, and has signed and dated the written ICF.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study:1)Has received rituximab (or a biosimilar product).2)Allergies or hypersensitivity to contrast agents for radiograph, murine, chimeric, human or humanised proteins.3)Evidence of histological transformation to high-grade or diffuse large B cell lymphoma.4))Known central nervous system involvement or any evidence of spinal cord compression by lymphoma.5)Has received previous treatment for NHL.6)Current diagnosis of active tuberculosis or other severe infections, such as sepsis, abscesses, or opportunistic infections.7)Infection with human immunodeficiency virus; hepatitis B or C.8)New York Heart Association class III or IV heart failure, severe uncontrolled cardiac disease, or myocardial infarction within the previous 6 months before the first administration of the study drug.9)Any malignancy other than NHL, except adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ, within the 5 years before the first administration of the study drug.10)Current or recent treatment with any other investigational medicinal product or device.11)Uncontrolled diabetes mellitus, even after insulin treatment.12)Is pregnant or lactating. Patients who are planning to be pregnant or to breastfeed before, during, or within 12 months after the last administration of the study drug are not permitted to enrol into the study.13)Is taking a live, live-attenuated, or nonlive vaccine within 4 weeks before the first administration of the study drug.14)Evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational product, or patient is high risk for treatment complications.
Countries
Australia, Chile, Czech Republic, Georgia, India, Israel, Italy, Korea South, Latvia, Malasya, Mexico, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactAndres Bayona
PPD Peru S.A.C.
Outcome results
None listed