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Clinical Trials List

Protocol NumberM20-638
NCT Number(ClinicalTrials.gov Identfier)NCT05409066
Active

2022-10-01 - 2030-05-31

Phase III

Recruiting5

A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)

  • Trial Applicant

    AbbVie

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉鴻霖 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator ZHENG-WEI ZHOU Division of Hematology & Oncology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hao-Yuan Wang 未分科
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Follicular Lymphoma (FL)

Objectives

This randomized Phase 3 clinical trial aims to evaluate the efficacy, safety, and tolerability of epcoritamab 48 mg combined with R2 compared with R2 alone in subjects with R/R FL. The primary efficacy endpoint was progression-free survival (PFS), which was defined as the time from the date of randomization to the date of disease progression or death (whichever occurred first) as assessed by the independent review committee (IRC) using the Lugano criteria.

Test Drug

Epcoritamab

Active Ingredient

Epcoritamab
Epcoritamab

Dosage Form

Concentrate for Solution for Injection
Concentrate for Solution for Injection

Dosage

4 mg/0.8 mL (5 mg/mL)
48 mg/0.8 mL (60 mg/mL)

Endpoints

Progression-free survival (PFS): defined as the time from the date of randomization to the date of disease progression assessed by the independent review committee (IRC) according to the Lugano criteria or death (whichever occurs first).

Inclution Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
Participant has:

Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
>= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI.
Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report.
Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)
Eligible to receive R2 per investigator determination.
Estimated Creatinine Clearance (CrCl) >= 50 mL/min.

Exclusion Criteria

Exclusion Criteria:

Documented refractoriness to lenalidomide.
Have lenalidomide exposure within 12 months prior to randomization.

The Estimated Number of Participants

  • Taiwan

    10 participants

  • Global

    500 participants

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