Phase 3
Completed N=140
To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan
Lymphoma, Follicular
Source: ClinicalTrials.gov NCT02162771 ↗
Enrolled (actual)
140
Serious AEs
26.4%
Results posted
Jan 2020
Primary outcomePrimary: Area Under the Serum Concentration-time Curve at Steady State (AUCtau) — 41002.43; 40099.08 h*ug/mL
◆ Published Evidence
Established
75citations · ~8 / year
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.
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.
Linked Publications (2)
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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.
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Long-term efficacy and safety of CT-P10 or rituximab in untreated advanced follicular lymphoma: a randomized phase 3 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Serum Concentration-time Curve at Steady State (AUCtau) |
41002.43; 40099.08 | — |
| PRIMARY Maximum Serum Concentration at Steady State (Cmax,ss) |
256.19; 254.49 | — |
| PRIMARY Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria |
64; 63 | — |
| SECONDARY B-cell Kinetics (B-cell Depletion and Recovery) |
92.5; 62.0; 20.0; 20.0; 20.0; 20.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is male or female older than 18 years.
- Patient has histologically confirmed FL according to the World Health Organization 2008 classification (Jaffe 2009); grades 1 to 3a based on local laboratory review.
- 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
- 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.)
- Patient has Ann Arbor stage III or IV disease.
Exclusion Criteria
- Patient has received rituximab (or a rituximab biosimilar), cyclophosphamide, or vincristine.
- Patient has allergies or hypersensitivity to murine, chimeric, human or humanised proteins, cyclophosphamide, vincristine, or prednisone.
- Patient has evidence of histological transformation to high-grade or diffuse large B-cell lymphoma.
- Patient has known central nervous system involvement.
- 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
Data sourced from ClinicalTrials.gov (NCT02162771) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.