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
| Tracking Information | |||||
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| First Received Date ICMJE | February 8, 2012 | ||||
| Last Updated Date | August 1, 2012 | ||||
| Start Date ICMJE | February 2012 | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
safety [ Time Frame: after 6 weeks of treatment begin ] [ Designated as safety issue: No ] Adverse events, including SAEs |
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| Original Primary Outcome Measures ICMJE |
safety [ Time Frame: after 2 cycles of treatment ] [ Designated as safety issue: No ] Adverse events, including SAEs |
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| Change History | Complete list of historical versions of study NCT01534949 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Provide Initial Evidence of Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy to Support the Pivotal CT-P10 Therapeutic Equivalence Trial | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | This study is designed to provide initial evidence of safety, pharmacokinetics, pharmacodynamics, and efficacy to support the pivotal CT-P10 therapeutic equivalence trial. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Diffuse Large B-Cell Lymphoma | ||||
| Intervention ICMJE | Biological: rituximab
375 mg/m2 by intravenous [IV] infusion |
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| Study Arm (s) | Experimental: CT-P10
rituximab
Intervention: Biological: rituximab |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 10 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01534949 | ||||
| Other Study ID Numbers ICMJE | CT-P10 1.2 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Celltrion | ||||
| Study Sponsor ICMJE | Celltrion | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Celltrion | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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