A Study to Compare Efficacy and Safety between CT-P10 and Rituxan in Patients with Low Tumour Burden Follicular Lymphoma

Phase 1

• Conditions: ow Tumour Burden Follicular Lymphoma.; MedDRA version: 20.0 Level: PT Classification code 10065856 Term: Non-Hodgkin's lymphoma unspecified histology indolent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005324-10-CZ
• Lead Sponsor: CELLTRION, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-18
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

1. Patient is male or female =18 years.
2. Patient has histologically confirmed CD20+ FL grade 1 to 3a according to the World Health Organization 2008 classification (Jaffe et al 2009); biopsy within 6 months before the first administration of the study drug.
3. Patient has at least 1 measurable tumour mass in 2 dimensions, and the mass must be:
• Nodal lesion >15 mm in the longest dimension; or
• Nodal lesion >10 mm to =15 mm in the longest dimension and >10 mm in the shortest dimension; or
• Extranodal lesion with both long and short dimensions =10 mm
4. Patient has Ann Arbor stage II, III, or IV disease.
5. Patient has low tumour burden, defined as based on Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria:
• No B symptoms,
• LDH < upper limit of normal (ULN),
• Largest nodal or extra mass <7 cm,
• <3 nodal sites with a diameter =3 cm,
• No significant serous effusions detectable clinically or on CT (small, clinically non-evident effusions on CT scan are not deemed significant),
• Spleen =16 cm by CT, and
• No clinical organ failure or organ compression (e.g. ureteric obstruction)
6. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (Oken et al 1982).
7. For both male and female patients and their partners of childbearing potential, patient agrees to practice true abstinence (when this is in line with preferred and usual lifestyle of the subject) 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 (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 the first administration of the study drug must agree to use 1 medically acceptable method of contraception or practice true abstinence during study treatment.
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.
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.
8. Patient has adequate bone marrow, hepatic, and renal function reserve as evidenced by:
• Haemoglobin level of =10 g/dL
• Absolute neutrophil count of =1500/mm3
• Platelet count of =100 000/mm3
• Total bilirubin level of =2.0 mg/dL
• Aspartate aminotransferase and alanine aminotransferase levels of =3 times the ULN for the reference laboratory (=5 × ULN for the reference laboratory with known hepatic involvement by lymphoma)

Exclusion Criteria

1. Patient has received rituximab (or a rituximab proposed biosimilar product).
2. Patient has allergies or hypersensitivity to contrast agents for radiograph, murine, chimeric, human or humanised proteins.
3. Patient has evidence of histological transformation to high-grade or diffuse large B-cell lymphoma.
4. Patient has known central nervous system involvement or any evidence of spinal cord compression by lymphoma.
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 within 4 weeks before the first administration of the study drug, with prednisone >20 mg per day (or equivalent doses of other steroid medications) for any purpose except NHL.
6. Patient has a severe infection, such as sepsis, abscesses, active tuberculosis (TB), or opportunistic infections.
7. Patient has a known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C (carriers of hepatitis B and hepatitis C are not permitted to enrol into the study).
8. Patient has New York Heart Association (Raphael et al 2007) class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina, clinically significant electrocardiogram [ECG] abnormalities), or myocardial infarction within the previous 6 months before the first administration of the study drug.
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 5 years before the first administration of the study drug.
10. Patient has a current or recent treatment (within 42 days before the first administration of the study drug or 5 times the half-life, whichever is longer, prior to screening) 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 administration of the study drug are not permitted to enrol into the study.
13. Patient is taking a live, live-attenuated, or nonlive vaccine within 4 weeks before the first administration of the study drug.
14. Patient has evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, unstable pulmonary condition, 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 at the investigator’s discretion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified