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

Celltrion258 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

258

Conditions

Follicular Lymphoma

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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.

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).

Data from ClinicalTrials.gov

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