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

Primary Purpose

Follicular Lymphoma

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CT-P10
Rituxan
Sponsored by
Celltrion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CT-P10

Rituxan

Arm Description

CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period

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.

Outcomes

Primary Outcome Measures

Primary Efficacy Endpoint - Overall Response Rate by 7 Months
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

Secondary Efficacy Endpoint - ORR Over the Study Period
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 PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery)
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
Secondary PK Endpoints - Ctrough
Secondary Efficacy Endpoint - Progression-free Survival (PFS)
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 - Overall Survival (OS)
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 - Time-to Progression (TTP)
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.

Full Information

First Posted
October 5, 2014
Last Updated
March 16, 2021
Sponsor
Celltrion
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1. Study Identification

Unique Protocol Identification Number
NCT02260804
Brief Title
To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 9, 2015 (Actual)
Primary Completion Date
January 4, 2018 (Actual)
Study Completion Date
September 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT-P10
Arm Type
Experimental
Arm Description
CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period
Arm Title
Rituxan
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
CT-P10
Intervention Description
375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.
Intervention Type
Biological
Intervention Name(s)
Rituxan
Intervention Description
375mg/m2, IV on day1 of 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint - Overall Response Rate by 7 Months
Description
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.
Time Frame
During the Month 7 (up to Maintenance Cycle 3; Week 28)
Secondary Outcome Measure Information:
Title
Secondary Efficacy Endpoint - ORR Over the Study Period
Description
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.
Time Frame
up to 27 months
Title
Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery)
Description
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.
Time Frame
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).
Title
Secondary PK Endpoints - Cmax
Time Frame
1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)
Title
Secondary PK Endpoints - Ctrough
Time Frame
1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)
Title
Secondary Efficacy Endpoint - Progression-free Survival (PFS)
Description
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.
Time Frame
Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).
Title
Secondary Efficacy Endpoint - Overall Survival (OS)
Description
Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses.
Time Frame
Overall study period (median follow-up of 29.2 months)
Title
Secondary Efficacy Endpoint - Time-to Progression (TTP)
Description
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.
Time Frame
Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SungHyun Kim
Organizational Affiliation
Celltrion
Official's Role
Study Director
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34686445
Citation
Kwak LW, Sancho JM, Cho SG, Nakazawa H, Suzumiya J, Tumyan G, Kim JS, Menne T, Mariz J, Ilyin N, Jurczak W, Lopez Martinez A, Samoilova O, Zhavrid E, Yanez Ruiz E, Trneny M, Popplewell L, Ogura M, Kim WS, Lee SJ, Kim SH, Ahn KY, Buske C. Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study. Clin Lymphoma Myeloma Leuk. 2022 Feb;22(2):89-97. doi: 10.1016/j.clml.2021.08.005. Epub 2021 Aug 28.
Results Reference
derived
PubMed Identifier
30389036
Citation
Ogura M, Sancho JM, Cho SG, Nakazawa H, Suzumiya J, Tumyan G, Kim JS, Lennard A, Mariz J, Ilyin N, Jurczak W, Lopez Martinez A, Samoilova O, Zhavrid E, Yanez Ruiz E, Trneny M, Popplewell L, Coiffier B, Buske C, Kim WS, Lee SJ, Lee SY, Bae YJ, Kwak LW. 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. Lancet Haematol. 2018 Nov;5(11):e543-e553. doi: 10.1016/S2352-3026(18)30157-1.
Results Reference
derived
Links:
URL
http://www.celltrion.com
Description
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To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma

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