Clinical trial NCT02162771: To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan
Official title: A Phase 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lymphoma, Follicular
Keywords: Advanced Follicular Lymphoma
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2014-06-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a Phase 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.


Eligibility 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

Primary outcomes:
measure: Area Under the Serum Concentration-time Curve at Steady State (AUCtau)
timeFrame: Core Cycle 4 (Week 12)
measure: Maximum Serum Concentration at Steady State (Cmax,ss)
timeFrame: Core Cycle 4 (Week 12)
measure: Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria
timeFrame: During the Core Study Period (up to 8 cycles; Week 24)
Secondary outcomes:
measure: B-cell Kinetics (B-cell Depletion and Recovery)
timeFrame: Cycles 1 to 8 during the Core Study Period
Other outcomes:
Locations:
Study officials:
References:
citation: Kim WS, Buske C, Ogura M, Jurczak W, Sancho JM, Zhavrid E, Kim JS, Hernandez-Rivas JA, Prokharau A, Vasilica M, Nagarkar R, Osmanov D, Kwak LW, Lee SJ, Lee SY, Bae YJ, Coiffier B. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial. Lancet Haematol. 2017 Aug;4(8):e362-e373. doi: 10.1016/S2352-3026(17)30120-5. Epub 2017 Jul 14.
citation: Buske C, Jurczak W, Sancho JM, Zhavrid E, Kim JS, Hernandez-Rivas JA, Prokharau A, Vasilica M, Nagarkar R, Kwak L, Kim WS, Lee S, Kim S, Ahn K, Ogura M. Long-term efficacy and safety of CT-P10 or rituximab in untreated advanced follicular lymphoma: a randomized phase 3 study. Blood Adv. 2021 Sep 14;5(17):3354-3361. doi: 10.1182/bloodadvances.2021004484.