Provide Initial Evidence of Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy to Support the Pivotal CT-P10 Therapeutic Equivalence Trial (Triad-DLBCL)

This study is currently recruiting participants.
Verified August 2012 by Celltrion
Sponsor:
Information provided by (Responsible Party):
Celltrion
ClinicalTrials.gov Identifier:
NCT01534949
First received: February 8, 2012
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

This study is designed to provide initial evidence of safety, pharmacokinetics, pharmacodynamics, and efficacy to support the pivotal CT-P10 therapeutic equivalence trial.


Condition Intervention Phase
Diffuse Large B-Cell Lymphoma
Biological: rituximab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-Label, Single-Arm Study to Evaluate the Initial Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of CT-P10 Given in Combination With Dexamethasone, Cytosine Arabinoside, and Cisplatin (DHAP) in Patients With Diffuse Large B-Cell Lymphoma as Second-Line Chemotherapy

Resource links provided by NLM:


Further study details as provided by Celltrion:

Primary Outcome Measures:
  • safety [ Time Frame: after 6 weeks of treatment begin ] [ Designated as safety issue: No ]
    Adverse events, including SAEs


Estimated Enrollment: 10
Study Start Date: February 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT-P10
rituximab
Biological: rituximab
375 mg/m2 by intravenous [IV] infusion

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has histologically proven DLBCL, which may represent de novo DLBCL or DLBCL arising from transformed follicular lymphoma or chronic lymphocytic leukemia.
  2. Patient has relapsed or refractory CD20-positive disease following previous first-line systemic chemotherapy. Patients who have failed to achieve complete remission with previous chemotherapy are defined as refractory, and those who relapsed after an initial complete remission are classified as having relapsed. A biopsy must be performed to confirm diagnosis of relapsed disease. Tumor tissue within 6 months of Day 1 of Cycle 1 of study treatment will be used for the central review.
  3. Patient has at least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension, or 1.1 to 1.5 cm in the longest dimension, and greater than 1.0 cm in the shortest axis) that has not previously been irradiated or has grown since previous irradiation

Exclusion Criteria:

  1. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.
  2. Patient has had prior allogeneic or ASCT.
  3. Patient has received any other anticancer therapy within 28 days before Day 1 of Cycle 1 of study treatment and more than 1 prior line of chemotherapy, with the exception of having received the last dose of rituximab within 6 months before Day 1 of Cycle 1 of study treatment if they have undergone prior treatment with rituximab.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534949

Contacts
Contact: Yonghui Jeong, BA +82 32 850 6558 YongHui.Jeong@celltrion.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Wonseog Kim, M.D., Ph.D.         
Sponsors and Collaborators
Celltrion
Investigators
Principal Investigator: Wonseog Kim, M.D., Ph.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01534949     History of Changes
Other Study ID Numbers: CT-P10 1.2
Study First Received: February 8, 2012
Last Updated: August 1, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Celltrion:
DLBCL, Biosimilar

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014