A study to Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma

A Phase 3, Randomised, Parallel-Group, Active-Controlled, Double Blind Study to Compare Efficacy and Safety between CT P10 and Rituxan in Patients with Low Tumour Burden Follicular Lymphoma - CT-P10 3.4

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/01/006493

Enrollment

174

Registered

2016-01-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C822- Follicular lymphoma grade III, unspecified Health Condition 2: null- Low Tumour Burden Follicular Lymphoma

Interventions

Intervention1: CT-P10 (Rituximab): CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period, and additional 12 cycles at maximum in maintenance period (1st year and 2nd year) Control I

Eligibility

Inclusion criteria

Inclusion criteria: Key brief inclusion criteria: •Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma grade 1 to 3a according to the World Health Organization 2008 classification •Ann Arbor Stage II, III or IV

Exclusion criteria

Exclusion criteria: Key brief exclusion criteria: •Has received rituximab •Allergies or hypersensitivity to murine, chimeric, human or humanised proteins •Previous treatment for NHL •Any malignancy, patient has known central nervous system involvement or any evidence of spinal cord compression by lymphoma •Current or recent treatment with any other investigational medicinal product or device •pregnant or lactating

Design outcomes

Secondary

Measure	Time frame
The secondary objectives are to assess additional efficacy parameters, pharmacokinetics, pharmacodynamics, overall safety, and biomarkers of CT-P10 incomparison with Rituxan.Timepoint: 1. Overall response rate during the study period â?¢ Progression-free survival, or death from any cause, whichever occurs first â?¢ Time to progressionor death as a result of lymphoma, whichever occurs first â?¢ Overall survival	—

Measure

Time frame

The secondary objectives are to assess additional efficacy parameters, pharmacokinetics, pharmacodynamics, overall safety, and biomarkers of CT-P10 incomparison with Rituxan.Timepoint: 1. Overall response rate during the study period â?¢ Progression-free survival, or death from any cause, whichever occurs first â?¢ Time to progressionor death as a result of lymphoma, whichever occurs first â?¢ Overall survival

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Primary

Measure	Time frame
Primary Objective: To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate (CR + CRu + PR) at 7 months (Prior to Cycle 3 of the Maintenance Study Period) according to the Modified Response Criteria for Malignant Lymphoma.Timepoint: At 7 months (Prior to Cycle 3 of the Maintenance Study Period) according to the Modified Response Criteria for Malignant Lymphoma.	—

Measure

Time frame

Primary Objective: To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate (CR + CRu + PR) at 7 months (Prior to Cycle 3 of the Maintenance Study Period) according to the Modified Response Criteria for Malignant Lymphoma.Timepoint: At 7 months (Prior to Cycle 3 of the Maintenance Study Period) according to the Modified Response Criteria for Malignant Lymphoma.

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Countries

Australia, Brazil, Chile, Czech Republic, Georgia, India, Israel, Italy, Latvia, Malaysia, Mexico, Peru, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States of America

Contacts

Public ContactArun Sundriyal

PPD Pharmaceutical Development India Private Limited

Arun.Sundriyal@ppdi.com911244739903

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026