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To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan

Information source: Celltrion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma, Follicular

Intervention: rituximab (Biological); CT-P10 (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Celltrion

Overall contact:
SunYoung Yu, Phone: 82 32 850 6559, Email: SunYoung.Yu@celltrion.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pharmacokinetics

Secondary outcome: Efficacy

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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

Locations and Contacts

SunYoung Yu, Phone: 82 32 850 6559, Email: SunYoung.Yu@celltrion.com

Hospital Universitario Germans Trias i Pujol, Barcelona, Badalona 08916, Spain; Recruiting
Additional Information

Starting date: June 2014
Last updated: April 24, 2015

Page last updated: August 23, 2015

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