NCT02260804

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 9, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2019

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

February 1, 2021

Enrollment Period

2.2 years

First QC Date

October 5, 2014

Results QC Date

January 21, 2021

Last Update Submit

March 16, 2021

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    During the Month 7 (up to Maintenance Cycle 3; Week 28)

Secondary Outcomes (7)

  • Secondary Efficacy Endpoint - ORR Over the Study Period

    up to 27 months

  • 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).

  • 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 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 Efficacy Endpoint - Progression-free Survival (PFS)

    Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).

  • +2 more secondary outcomes

Study Arms (2)

CT-P10

EXPERIMENTAL

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

Biological: CT-P10

Rituxan

ACTIVE COMPARATOR

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.

Biological: Rituxan

Interventions

CT-P10BIOLOGICAL

375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.

CT-P10
RituxanBIOLOGICAL

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.

Rituxan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma
  • Ann Arbor Stage II, III or IV

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 34686445DERIVED

  • 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.

    PMID: 30389036DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

CT-P10Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

In this study, TTE endpoints were secondary endpoints and were not powered. As medians of PFS, TTP, and OS were not reached in both treatment groups, longer follow-up is needed to ascertain the median time for TTE parameters of PFS, TTP, and OS.

Results Point of Contact

Title
Dr. Sung Hyun Kim
Organization
CELLTRION, Inc.
contact@celltrion.com
+82-32-850-5000

Study Officials

  • SungHyun Kim

    Celltrion

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2014

First Posted

October 9, 2014

Study Start

November 9, 2015

Primary Completion

January 4, 2018

Study Completion

September 4, 2019

Last Updated

April 8, 2021

Results First Posted

April 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)