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:
Celltrion
Information provided by (Responsible Party):
Celltrion
ClinicalTrials.gov Identifier:
NCT01534949
First received: February 8, 2012
Last updated: August 1, 2012
Last verified: August 2012
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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:
- Patient has histologically proven DLBCL, which may represent de novo DLBCL or DLBCL arising from transformed follicular lymphoma or chronic lymphocytic leukemia.
- 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.
- 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:
- Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.
- Patient has had prior allogeneic or ASCT.
- 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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 21, 2013