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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


Phase 1
21 Years
70 Years
Open (Enrolling)
Both
Diffuse Large B-Cell Lymphoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

safety

Outcome Description:

Adverse events, including SAEs

Outcome Time Frame:

after 6 weeks of treatment begin

Safety Issue:

No

Principal Investigator

Wonseog Kim, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

CT-P10 1.2

NCT ID:

NCT01534949

Start Date:

February 2012

Completion Date:

Related Keywords:

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

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