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
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