Overview

This trial is active, not recruiting.

Condition lymphoma, follicular
Treatments rituximab, ct-p10
Phase phase 3
Target CD20
Sponsor Celltrion
Start date June 2014
End date February 2017
Trial size 134 participants
Trial identifier NCT02162771, 2013-004493-96, CT-P10 3.3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
CT-P10 will be administrated upto maximum of 8 cycles during the Core Study Period with CVP(cyclophosphamide, vincristine, prednisone) every 3 weeks. CT-P10 or Rituxan (375 mg/m2 IV) will be administered alone as maintenance in patients who have a response during the Core Study Period.
rituximab Rituxan
(Active Comparator)
rituximab(Rituxan) will be administrated upto maximum of 8 cycles during the Core Study Period with CVP(cyclophosphamide, vincristine, prednisone) every 3 weeks. CT-P10 or Rituxan (375 mg/m2 IV) will be administered alone as maintenance in patients who have a response during the Core Study Period.
ct-p10 rituximab

Primary Outcomes

Measure
Pharmacokinetics
time frame: Week 12

Secondary Outcomes

Measure
Efficacy
time frame: Week 24

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase 1/3, Randomised, Parallel-Group, Active-Controlled, Double-Blind Study to Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan, Each Administered in Combination With Cyclophosphamide, Vincristine, and Prednisone (CVP) in Patients With Advanced Follicular Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Celltrion.