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

February 8, 2012
August 1, 2012
February 2012
October 2012   (final data collection date for primary outcome measure)
safety [ Time Frame: after 6 weeks of treatment begin ] [ Designated as safety issue: No ]
Adverse events, including SAEs
safety [ Time Frame: after 2 cycles of treatment ] [ Designated as safety issue: No ]
Adverse events, including SAEs
Complete list of historical versions of study NCT01534949 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Provide Initial Evidence of Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy to Support the Pivotal CT-P10 Therapeutic Equivalence Trial
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

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

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diffuse Large B-Cell Lymphoma
Biological: rituximab
375 mg/m2 by intravenous [IV] infusion
Experimental: CT-P10
rituximab
Intervention: Biological: rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Not Provided
October 2012   (final data collection date for primary outcome measure)

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.
Both
21 Years to 70 Years
No
Contact: Yonghui Jeong, BA +82 32 850 6558 YongHui.Jeong@celltrion.com
Korea, Republic of
 
NCT01534949
CT-P10 1.2
Yes
Celltrion
Celltrion
Not Provided
Principal Investigator: Wonseog Kim, M.D., Ph.D. Samsung Medical Center
Celltrion
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP