Phase 3
Completed N=258
To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
Source: ClinicalTrials.gov NCT02260804 ↗Enrolled (actual)
258
Serious AEs
10.9%
Results posted
Apr 2021
Primary outcomePrimary: Primary Efficacy Endpoint - Overall Response Rate by 7 Months — 108; 104 Participants
◆ Published Evidence
Established
63citations · ~8 / year
Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial.
Summary
To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months
Linked Publications (2)
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Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial.
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Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy Endpoint - Overall Response Rate by 7 Months |
108; 104 | — |
| SECONDARY Secondary Efficacy Endpoint - ORR Over the Study Period |
109; 112 | — |
| SECONDARY Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery) |
95.0; 120.0; 20.0; 20.0; 20.0; 20.0 | — |
| SECONDARY Secondary PK Endpoints - Cmax |
212.86; 217.38; 283.35; 285.98; 327.32; 341.59 | — |
| SECONDARY Secondary PK Endpoints - Ctrough |
64.66; 72.94; 113.23; 120.92; 149.53; 161.80 | — |
| SECONDARY Secondary Efficacy Endpoint - Progression-free Survival (PFS) |
0.93; 0.89; 0.88; 0.83; 0.80; 0.68 | — |
| SECONDARY Secondary Efficacy Endpoint - Overall Survival (OS) |
0.98; 0.98; 0.98; 0.98; 0.98; 0.97 | — |
| SECONDARY Secondary Efficacy Endpoint - Time-to Progression (TTP) |
0.94; 0.89; 0.89; 0.84; 0.82; 0.68 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma
- Ann Arbor Stage II, III or IV
Exclusion Criteria
- Has receive rituximab
- Allergies or hypersensitivity to murine, chimeric, human or humanised proteins
- Previous treatment for NHL
- Any malignancy
- Current or recent treatment with any other investigational medicinal product or device
- pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT02260804) 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.