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

Diffuse Large B-Cell Lymphoma Clinical Trial

— Triad-DLBCL  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01534949
• Other study ID #: CT-P10 1.2
• Status: Terminated
• Phase: Phase 1
• First received: February 8, 2012
• Last updated: July 21, 2014
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: July 2014
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Biological:
• rituximab
375 mg/m2 by intravenous [IV] infusion

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety	Adverse events, including SAEs	after 6 weeks of treatment begin	No