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Clinical Trials List

Protocol NumberGCT3013-05
NCT Number(ClinicalTrials.gov Identfier)NCT04628494
Completed

2021-11-01 - 2028-04-14

Phase III

Recruiting5

ICD-10C82.50

Diffuse follicle center lymphoma, unspecified site

ICD-10C82.59

Diffuse follicle center lymphoma, extranodal and solid organ sites

ICD-10C83.10

Mantle cell lymphoma, unspecified site

ICD-10C83.19

Mantle cell lymphoma, extranodal and solid organ sites

ICD-10C83.30

Diffuse large B-cell lymphoma, unspecified site

ICD-10C83.39

Diffuse large B-cell lymphoma, extranodal and solid organ sites

ICD-10C83.80

Other non-follicular lymphoma, unspecified site

ICD-10C83.89

Other non-follicular lymphoma, extranodal and solid organ sites

ICD-10C84.90

Mature T/NK-cell lymphomas, unspecified, unspecified site

ICD-10C84.99

Mature T/NK-cell lymphomas, unspecified, extranodal and solid organ sites

ICD-10C84.A0

Cutaneous T-cell lymphoma, unspecified, unspecified site

ICD-10C84.A9

Cutaneous T-cell lymphoma, unspecified, extranodal and solid organ sites

ICD-10C84.Z0

Other mature T/NK-cell lymphomas, unspecified site

ICD-10C84.Z9

Other mature T/NK-cell lymphomas, extranodal and solid organ sites

ICD-10C85.10

Unspecified B-cell lymphoma, unspecified site

ICD-10C85.19

Unspecified B-cell lymphoma, extranodal and solid organ sites

ICD-10C85.20

Mediastinal (thymic) large B-cell lymphoma, unspecified site

ICD-10C85.29

Mediastinal (thymic) large B-cell lymphoma, extranodal and solid organ sites

ICD-10C85.80

Other specified types of non-Hodgkin lymphoma, unspecified site

ICD-10C85.89

Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites

ICD-10C85.90

Non-Hodgkin lymphoma, unspecified, unspecified site

ICD-10C85.99

Non-Hodgkin lymphoma, unspecified, extranodal and solid organ sites

ICD-10C86.4

Blastic NK-cell lymphoma

ICD-10C88.4

Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue [MALT-lymphoma]

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9202.80

Other lymphomas, unspecified, extranodal solid organ sites

A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 陳宇欽 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tai-Chung Huang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蔡淳光 Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hui-Hua Hsiao Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Diffuse Large B-cell Lymphoma

Objectives

In subjects with relapsed/refractory diffuse large B-cell lymphoma who have failed HDT-ASCT or are ineligible for HDT-ASCT, the efficacy of epcoritamab compared to chemotherapy selected by the trial administrator was evaluated.

Test Drug

皮下注射劑

Active Ingredient

EPCORITAMAB

Dosage Form

220

Dosage

0.8ml

Endpoints

Key assessment metrics:

- Overall survival (OS)

- Progression-free survival (PFS) as determined by the Independent Review Committee (IRC) using the Lugano criteria

Inclution Criteria

Main Inclusion Criteria:

Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 monoclonal antibody (mAb)-containing combination chemotherapy since lymphoma diagnosis
One of the confirmed histologies below with CD20-positivity:

DLBCL, not otherwise specified (NOS), including de novo or histologically transformed from follicular lymphoma (FL)
"Double-hit" or "triple-hit" DLBCL (technically classified in World Health Organization (WHO) 2016 as high-grade B-cell lymphoma (HGBCL), with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL
FL Grade 3B
T-cell/histiocyte-rich large B-cell lymphoma
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2
Failed previous HDT-ASCT or not eligible for high-dose therapy autologous stem cell transplant (HDT-ASCT) at screening
Participants must have detectable disease by positron emission tomography (PET) scan and measurable by computed tomography (CT) scan or magnetic resonance imaging (MRI)
Acceptable renal and liver function
Life expectancy >2 months on standard of care treatment

Exclusion Criteria

Main Exclusion Criteria:

Primary Central Nervous System (CNS) tumor or known CNS involvement
Any prior therapy with a bispecific antibody targeting CD3 and CD20
Major surgery within 4 weeks prior to randomization
Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
Autologous stem cell transplant (ASCT) within 100 days of randomization
Treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to randomization
Seizure disorder requiring anti-epileptic therapy
Clinically significant cardiac disease

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    480 participants

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