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OpenTrials
Completed

NCT Number: NCT02260804

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

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Key information

Conditions

Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT-P10

Biological

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

Rituxan

Biological

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 outcomes

  1. 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.

Secondary outcomes

  1. Secondary Efficacy Endpoint - ORR Over the Study Period

    Time frame: up to 27 months

    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.

  2. 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).

    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.

  3. 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)

  4. 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)

  5. Secondary Efficacy Endpoint - Progression-free Survival (PFS)

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

    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.

  6. Secondary Efficacy Endpoint - Overall Survival (OS)

    Time frame: Overall study period (median follow-up of 29.2 months)

    Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses.

  7. Secondary Efficacy Endpoint - Time-to Progression (TTP)

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

    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.

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Oct 9, 2014
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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