Clinical trial NCT02260804: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Follicular Lymphoma
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Primary Efficacy Endpoint - Overall Response Rate by 7 Months
timeFrame: During the Month 7 (up to Maintenance Cycle 3; Week 28)
Secondary outcomes:
measure: Secondary Efficacy Endpoint - ORR Over the Study Period
timeFrame: up to 27 months
measure: Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery)
timeFrame: 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).
measure: Secondary PK Endpoints - Cmax
timeFrame: 1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)
measure: Secondary PK Endpoints - Ctrough
timeFrame: 1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)
measure: Secondary Efficacy Endpoint - Progression-free Survival (PFS)
timeFrame: Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).
measure: Secondary Efficacy Endpoint - Overall Survival (OS)
timeFrame: Overall study period (median follow-up of 29.2 months)
measure: Secondary Efficacy Endpoint - Time-to Progression (TTP)
timeFrame: Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Celltrion
name: SungHyun Kim
role: STUDY_DIRECTOR
References:
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.
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.