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Trial record 1 of 21 for:    ct -p10 and rituxan
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To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma

This study is currently recruiting participants.
Verified June 2017 by Celltrion
Sponsor:
ClinicalTrials.gov Identifier:
NCT02260804
First Posted: October 9, 2014
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Celltrion
  Purpose
To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months

Condition Intervention Phase
Follicular Lymphoma Biological: CT-P10 Biological: Rituxan Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Celltrion:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 7months ]

Estimated Enrollment: 174
Study Start Date: July 2015
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT-P10
CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period
Biological: CT-P10
375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.
Active Comparator: Rituxan
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
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260804


Contacts
Contact: MinJi Ma +82328506727 minji.ma@celltrion.com
Contact: EnDa Ko +82328506655 EnDa.Ko@celltrion.com

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jin Seok Kim         
Sponsors and Collaborators
Celltrion
Investigators
Study Director: SungYoung Lee Celltrion
  More Information

Additional Information:
Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT02260804     History of Changes
Other Study ID Numbers: CT-P10 3.4
First Submitted: October 5, 2014
First Posted: October 9, 2014
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Rituximab
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents