The purpose of this study is to demonstrate that CT-P10 (the drug under investigation) works as effectively and safely as Rituxan in Patients with untreated advanced follicular lymphoma. The study is also investigating the pharmacokinetic similarity (the amount of drug or its breakdown in the body over a period of time) and the pharmacodynamics (the effect a drug has on the body), and overall safety and efficacy of CT-P10 in comparison with Rituxan.
- Conditions
- Advanced Follicular LymphomaMedDRA version: 16.1 Level: PT Classification code 10016910 Term: Follicle centre lymphoma, follicular grade I, II, III stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1 Level: PT Classification code 10016909 Term: Follicle centre lymphoma, follicular grade I, II, III stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-004493-96-ES
- Lead Sponsor
- CELLTRION, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
Each patient must meet all of the following criteria to be enrolled in this study:
1. Patient is male or female older than 18 years.
2. Patient has histologically confirmed FL according to the World Health Organization 2008 classification (Jaffe 2009); grades 1 to 3a based on local laboratory review.
3. Patient has at least 1 measurable tumour mass that has not previously been irradiated, and the mass must be:
- greater than 1.5 cm in the longest dimension or
- between 1.1 and 1.5 cm in the longest dimension and greater than 1.0 cm in the shortest axis
4. Patient has confirmed CD20+ lymphoma, as assessed by local 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 (ECOG) performance status of 0 to 2 (Oken 1982).
7. For both 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 treatment (excluding women who are not of childbearing potential and men who have been sterilised):
- 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 or female patients and their partners who have been surgically sterilised for less than 6 months prior to study entry must agree to use 1 medically acceptable method of contraception or practice total abstinence. 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.
8. For both premenopausal women and women who are less than or equal to 12 months after the onset of menopause, patient has a negative serum pregnancy test during the Screening Period.
9. Patient has adequate bone marrow, hepatic, and renal function reserve as evidenced by:
- Haemoglobin level of >= 8 g/dL
- Absolute neutrophil count (ANC) of >= 1500/mm3
- Platelet count of >= 75 000/mm3
- Total bilirubin level of <= 2.0 mg/dL
- Aspartate aminotransferase and alanine aminotransferase levels of <= 3 times the upper limit of normal (ULN) for the reference laboratory (<= 5 × ULN for the reference laboratory with known hepatic involvement by lymphoma)
- A serum creatinine level of <= 1.5 × ULN for the reference laboratory, or a calculated creatinine clearance by the Cockcroft-Gault equation (Rostoker et al 2007) of >= 50 mL/min
10. Patient is able to understand verbal and written instructions and can comply with all study requirements.
11. 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
Patients meeting any of the following criteria will be excluded from the study:
1. Patient has received rituximab (or a rituximab biosimilar), cyclophosphamide, or vincristine.
2. Patient has allergies or hypersensitivity to murine, chimeric, human or humanised proteins, cyclophosphamide, vincristine, or prednisone.
3. Patient has evidence of histological transformation to high-grade or diffuse large B-cell lymphoma.
4. Patient has known central nervous system involvement.
5. Patient has received previous treatment for NHL:
- Previous treatment including chemotherapy, radiotherapy, immunotherapy, and/or surgery (except previous biopsy)
- All doses of corticoid therapy for treatment of NHL
- Corticoid therapy during the previous 4 weeks from Day 1 of Cycle 1 with prednisone >20 mg per day for the treatment for any purpose
6. Patient has a current diagnosis of active 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 (HIV), hepatitis B, or hepatitis C. (Carriers of hepatitis B are not permitted to enrol 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 before the ICF is signed.
9. Patient has any malignancy other than NHL, except adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ, within the previous 5 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 uncontrolled diabetes mellitus, even after insulin treatment.
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 enrol into the study.
13. Patient is taking a live, live-attenuated, or nonlive vaccine within 4 weeks before Day 1 of Cycle 1 of study treatment.
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 the 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