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Clinical Trials List

Protocol NumberM22-003

NCT Number(ClinicalTrials.gov Identfier)NCT06191744

Active

2024-02-01 - 2038-01-31

Phase III

Recruiting4

A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

Trial Applicant

AbbVie
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator 滕傑林無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tai-Chung Huang 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Su-Peng Yeh 無

China Medical University 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

Follicular Lymphoma (FL)

Objectives

This study evaluated the safety and efficacy of epcoritamab with R2 versus standard care in previously untreated flaccid patients. The primary endpoint was CR30 in group A (ER2) versus group B (CIT), assessed by an independent evaluation committee (IRC) using positron emission tomography (PET) computed tomography (CT) scans according to the Lugano 2014 criteria.

Test Drug

Active Ingredient

Epcoritamab
1008200300
1013004400
1013002400
Cyclophosphamide
1003000610
1002000210
6804001800
1004002510
CYCLOPHOSPHAMIDE

Dosage Form

187
187
187
187
187
187
187
187
187
187
187

Dosage

N/A
NA

Endpoints

The primary objective of this trial is to demonstrate that, compared to chemoimmunotherapy (CIT), epcoritamab plus R2 (ER2) improves the CR30 (complete response at 30 months) rate in previously untreated FL patients.

Inclution Criteria

Inclusion Criteria:

Diagnosis of follicular lymphoma (FL).
Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
Are willing and able to comply with procedures required in the protocol.
Must have stage, III, IV or II with bulky disease >= 7cm).
Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
Has one or more target lesions:

A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
>=1 measurable nodal lesion (long axis >1.5cm) or >=1 measurable extra-nodal lesion (long axis >1.0 cm) on CT scan or MRI
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: [Arm B] at the discretion of the Investigator, and rituximab and lenalidomide (R2) [Arm C].
Have laboratory values meeting the criteria in the protocol.

Exclusion Criteria

Exclusion Criteria:

Had major surgery within 4 weeks prior to randomization.
Have active cytomegalovirus (CMV) disease.

The Estimated Number of Participants

Taiwan

16 participants
Global

1095 participants