Follicular LymphomaPhase 3NCT02260804

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

A Phase 3 study testing CT-P10 and Rituxan in people with Follicular Lymphoma, run by Celltrion at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Follicular Lymphoma
What is being tested?: CT-P10 and Rituxan
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 258 participants
Where: 1 siteSouth Korea
Study dates: 9 Nov 2015to 4 Sep 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Severance Hospital
Seoul

Other trials in South Korea

About this study

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

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

Conditions: Follicular Lymphoma
Being tested: CT-P10, Rituxan
Medical subject headings: Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-P10Biological
375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.
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.

Study groups in NCT02260804
Study group	Role	What they receive
CT-P10	Experimental	CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period Receives: 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. Receives: Biological: Rituxan

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

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.
Measured: up to 27 months
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.
Measured: 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
Measured: 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
Measured: 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)
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.
Measured: Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).
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.
Measured: Overall study period (median follow-up of 29.2 months)
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.
Measured: Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 20154 Sep 2019

First posted9 Oct 2014 (estimated)
Study start9 Nov 2015
Primary completion4 Jan 2018
Study completion4 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Follicular LymphomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02260804
Sponsor's protocol ID: CT-P10 3.4
Status last verified: Feb 2021
First submitted: 5 Oct 2014
Last updated: 8 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 34686445
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.
PubMed 30389036

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Follicular Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02260804
Acronym / sponsor ID: CT-P10 3.4
Conditions: Follicular Lymphoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 258 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Study start: 9 Nov 2015 (actual)
Primary completion: 4 Jan 2018 (actual)
Study completion: 4 Sep 2019 (actual)
First posted: 9 Oct 2014 (estimated)
Results: Posted 8 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CT-P10	Experimental	Biological: CT-P10CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period
Rituxan	Active comparator	Biological: RituxanRituxan, 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT-P10375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.	Biological	CT-P10
Rituxan375mg/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.	Biological	Rituxan

Primary outcome

Primary Efficacy Endpoint - Overall Response Rate by 7 Months
Time frame: 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.

7 secondary outcomes

Secondary Efficacy Endpoint - ORR Over the Study Period
Time frame: up to 27 months
Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery)
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).
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)
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)
Secondary Efficacy Endpoint - Progression-free Survival (PFS)
Time frame: Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).
Secondary Efficacy Endpoint - Overall Survival (OS)
Time frame: Overall study period (median follow-up of 29.2 months)
Secondary Efficacy Endpoint - Time-to Progression (TTP)
Time frame: Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).

Results and safety

Results posted to the registry on 8 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CT-P10	130	128
Rituxan	128	128

Primary outcome: Primary Efficacy Endpoint - Overall Response Rate by 7 Months

Time frame: During the Month 7 (up to Maintenance Cycle 3; Week 28). Count of participants. Unit: Participants

Measure	CT-P10 n = 130	Rituxan n = 128
Value	108	104

CT-P10: Difference in proportion: 1.8 (90% CI -6.43 to 10.2)

Population analysed: The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from the last dose of the study drug, regardless of the relationship to the study drug. data from the overall study period (median follow-up of 29.2 months) are presented.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CT-P10	14 of 130 (10.8%)	93 of 130 (71.5%)	3 of 130
Rituxan	14 of 128 (10.9%)	86 of 128 (67.2%)	3 of 128

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34686445Kwak 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.
Derived from this study: PubMed 30389036Ogura 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Follicular Lymphoma

RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
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EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

SungHyun Kim study director

Celltrion

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CT-P10 and Rituxan in people with Follicular Lymphoma, run by Celltrion at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy Endpoint - Overall Response Rate by 7 Months (time frame: During the Month 7 (up to Maintenance Cycle 3; Week 28)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02260804, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.