A randomized Phase III clinical trial to compare the efficacy and safety of the biosimilar rituximab CT-P10 in combination with a standard chemotherapy (CVP) or rituximab MabThera in combination with a standard chemotherapy (CVP),in patient with previously untreated advanced stage follicular lymphoma.
- Conditions
- Advanced Follicular LymphomaMedDRA version: 14.0Level: PTClassification code 10016910Term: Follicle centre lymphoma, follicular grade I, II, III stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: PTClassification code 10016909Term: Follicle centre lymphoma, follicular grade I, II, III stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-002813-12-ES
- Lead Sponsor
- CELLTRION, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 740
Each patient must meet all of the following criteria to be enrolled in this study:
1. Patient is male or female between 18 and 75 years old, inclusive.
2. Patient has histologically confirmed FL according to the Revised European-American Lymphoma/World Health Organization classification; grades 1 to 3 based on local practice.
3. Patient has at least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension or 1.1 to 1.5 cm in the longest dimension and greater than 1.0 cm in the shortest axis) that has not previously been irradiated.
4. Patient has confirmed CD20+ lymphoma, as assessed by central laboratory review. (Tissue obtained within 6 months before Day 1 of Cycle 1 will be reviewed by a central independent reviewer to detect pathological type.)
5. Patient has Ann Arbor stage III or IV disease.
6. Patient has an Eastern Cooperative Oncology Group performance status of 0 to 2.
7. Patient has a life expectancy of more than 6 months.
8. Patient needs treatment for FL in the opinion of the participating clinician.
9. For both male and female patients and their partners of childbearing potential, patient agrees to use one of the following medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study treatment (excluding women who are not of childbearing potential and men who have been sterilized):
- Barrier contraceptives (male condom, female condom or diaphragm with a spermicidal gel)
- Hormonal contraceptives (implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings)
- Intrauterine devices.
Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to study entry must agree to use 1 medically acceptable method of contraception.
Menopausal females must have experienced their last period more than 12 months prior to study entry (ie, when the informed consent form [ICF] is signed) to be classified as not of childbearing potential.
10. For both premenopausal women and women who are less than 2 years after the onset of menopause, patient has a negative serum pregnancy test during the Screening Period or within 4 weeks before Day 1 of Cycle 1 of study treatment.
11. Patient has adequate bone marrow, hepatic, and renal function reserve as evidenced by:
- hemoglobin level of > or = 10 g/dL
- absolute neutrophil count of > or =1500/microL
- platelet count of > or =100 000/microL
- total bilirubin level of < or = 2.0 mg/dL
- aspartate aminotransferase and alanine aminotransferase levels of < or = 3 times the upper limit of normal (ULN) for the reference laboratory (< or = 5 × ULN for the reference laboratory with known hepatic involvement by lymphoma)
- A serum creatinine level of < or = 1.5 × ULN for the reference laboratory, or a calculated creatinine clearance by the Cockroft-Gault equation (Rostoker et al 2007) of > or = 50 mL/min.
12. Patient is able to understand verbal and written instructions and can comply with all study requirements.
13. Patient is informed, given ample time and opportunity to read and understand about participation in the study, and has signed and dated the written ICF.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 370
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 370
1. Patient has allergies or hypersensitivity to murine, chimeric, human or humanized proteins, cyclophosphamide, vincristine, or prednisone.
2. Patient has evidence of histologically transformation to high-grade or diffuse large B cell lymphoma.
3. Patient has known central nervous system involvement.
4. Patient has received previous treatment for non-Hodgkin's lymphoma.
5. Patient has had recent radiotherapy or major surgery within 4 weeks before Day 1 of Cycle 1, except lymph node biopsy.
6. Patient has a current diagnosis of tuberculosis (TB) defined by chest x-ray or other severe infections, such as sepsis, abscesses, or opportunistic infections.
7. Patient has a known infection with human immunodeficiency virus, hepatitis B, or hepatitis C infection. (carriers of hepatitis B are not permitted to enroll into the study).
8. Patient has New York Heart Association class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina, arrhythmias, clinically significant electrocardiogram [ECG] abnormalities), or myocardial infarction within the previous 6 months prior to the date of consent.
9. Patient has any malignancy other than non-Hodgkin's lymphoma, except adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ, within the previous 3 years before the ICF is signed.
10. Patient has a current or recent (within 30 days before the ICF is signed) treatment with any other investigational medicinal product or device.
11. Patient has diabetes mellitus, except well-controlled type 2 diabetes mellitus. Well-controlled type 2 diabetes mellitus will be judged by each investigator.
12. Patient is pregnant or lactating. Patients who are planning to be pregnant or to breastfeed before, during, or within 12 months after the last infusion of study treatment are not permitted to enroll into the study.
13. Patient is taking a live or live-attenuated vaccine within 8 weeks before Day 1 of Cycle 1 of study treatment or a killed vaccine within 4 weeks before Day 1 of Cycle 1 of study treatment. Live or live-attenuated vaccines are not permitted during the study.
14. Patient has 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 use of an investigational product, or patient is a high risk for treatment complications.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method