To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan
Conditions
Lymphoma, Follicular
Conditions: official terms
Lymphoma, Follicular
Conditions: Keywords
Advanced Follicular Lymphoma
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: rituximab Type: Biological
Name: CT-P10 Type: Biological
Overall Status
Recruiting
Summary
This study is a Phase 1/3 prospective, randomised, parallel-group, active controlled, double blind, multicentre, international study with 2 coprimary endpoints designed to demonstrate equivalence in pharmacokinetics (Part 1), as well as noninferiority in efficacy (Part 2), of CT-P10 to Rituxan when coadministered with CVP and to assess efficacy and safety in patients with advanced (stage III-IV) FL. Part 1 and Part 2 of the study will run in parallel.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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
Location
Hospital Universitario Germans Trias i Pujol
Barcelona, Badalona, Spain
Status: Recruiting
Start Date
June 2014
Completion Date
June 2020
Sponsors
Celltrion
Source
Celltrion
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page