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

Phase 3

Completed

• Conditions: Follicular Lymphoma
• Interventions: Biological: CT-P10; Biological: Rituxan

• Registration Number: NCT02260804
• Lead Sponsor: Celltrion

Brief Summary

To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-05
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-09
• Study Start: 2015-11-09
• Primary Completion: 2018-01-04
• Study Completion: 2019-09-04
• Results First Submitted: 2021-01-21
• Status Verified: 2021-02
• Results First Submitted QC: 2021-03-16
• Last Update Submitted: 2021-03-16
• Results First Posted: 2021-04-08
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P10	CT-P10	CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period
Rituxan	Rituxan	Rituxan, 375mg/m2 intravenous, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint - Overall Response Rate by 7 Months	During the Month 7 (up to Maintenance Cycle 3; Week 28)	ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR) by central review.; Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: \>75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.

Secondary Outcome Measures

Name	Time	Method
Secondary Efficacy Endpoint - Overall Survival (OS)	Overall study period (median follow-up of 29.2 months)	Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses.
Secondary Efficacy Endpoint - ORR Over the Study Period	up to 27 months	ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR).; Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: \>75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.
Secondary PK Endpoints - Ctrough	1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)
Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery)	Baseline, Induction Cycle 1 (predose, 1 hr postdose), Induction Cycle 2 to 4 (predose), EOT1/EOT2 (anytime), Maintenance Cycle 1 to 2 (predose, 1hr postdose) and Maintenance Cycle 3 (predose).	B-cell kinetics were demonstrated by median values of B-cell counts. Any values below the LLoQ were set as LLoQ which was 20 cells/μL.
Secondary PK Endpoints - Cmax	1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)
Secondary Efficacy Endpoint - Progression-free Survival (PFS)	Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).	PFS was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death from any cause, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses.
Secondary Efficacy Endpoint - Time-to Progression (TTP)	Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).	Time to progression was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death as a result of lymphoma, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of