問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberR1979-HM-2298
NCT Number(ClinicalTrials.gov Identfier)NCT06091254
Active

2023-07-01 - 2029-07-01

Phase III

Recruiting12

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)

  • Trial Applicant

    ICON Clinical Research Pte Ltd

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator YAO CHI-YUAN Division of Others -
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung Chang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSU-YI CHAO Division of Hematology & Oncology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳志丞 Division of Hematology & Oncology
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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 Tzeon-jye Chiou Division of Hematology & Oncology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shih-Feng Cho 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 王全正 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HSIN-CHEN LIN Division of Hematology & Oncology
Taichung 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

Principal Investigator 邱玲榕 無
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 Chia-Jen Liu Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Follicular Lymphoma (FL)

Objectives

part 1: Primary objective: To evaluate the safety, tolerability, and dose-limiting toxicities (DLT) of odronextamab in participants with treatment-naïve follicular lymphoma (FL) Secondary goals: ‧ Describe the pharmacokinetic (PK) properties of odronextamab ‧ Evaluating the immunogenicity of odronextamab ‧ Evaluating the preliminary anti-tumor activity of odronextamab part 2: Primary objective: To compare the efficacy of odronextamab versus the trial moderator's choice of therapy in participants with previously untreated FL, as measured by independent central reviewer-adjusted complete response (CR30) at 30 months Key secondary goals: ‧ Comparing the efficacy of odronextamab monotherapy to the trial moderator's chosen chemotherapy as judged by independent central reviewers on: o Progression-free survival (PFS) o Event-free survival (EFS) ‧ Compare the efficacy of odronextamab monotherapy to the trial moderator’s choice of chemotherapy, as assessed by the trial moderator’s CR30 ‧ To assess the therapeutic effect of odronextamab monotherapy versus the trial moderator's chosen chemotherapy on patient-reported physiological function using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Secondary goals: ‧ To assess additional efficacy measures of odronextamab compared to the trial sponsor’s choice of chemotherapy ‧ To assess the safety and tolerability of odronextamab compared with trial moderators’ choice of chemotherapy ‧ Evaluate the pharmacokinetics (PK) of odronextamab ‧ Evaluating the immunogenicity of odronextamab ‧ To assess the impact of odronextamab on patient-reported outcomes (PROs), including health-related quality of life (HRQoL), compared with trial moderators' chosen therapy, as measured by EORTC-QLQ-C30, Functional Assessment of Cancer Therapies-Lymphoma (FACT) -LymS), Patient's Global Impression of Severity (PGIS), Patient's Global Impression of Change (PGIC) and European Quality of Life Five-Level Questionnaire (EQ-5D-5L) ‧ Assess the overall impact of patient-reported treatment toxicities based on GP5 items of the Functional Assessment of Cancer - General (FACT-G) questionnaire

Test Drug

Odronextamab

Active Ingredient

Odronextamab

Dosage Form

Sterile solution

Dosage

2 mg/mL、20 mg/mL

Endpoints

part 1
‧ Incidence of DLT with odronextamab during DLT observation period
‧ Incidence and severity of treatment-emergent adverse events (TEAEs) with Odronextamab
part 2
Complete response at 30 months (CR30) as assessed at week 120 by an independent central reviewer according to the Lugano classification (Cheson, 2014a)

Inclution Criteria

Key Inclusion Criteria:

Diagnosis of cluster of differentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / IV
Need for treatment as described in the protocol
Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed tomography (CT) or Magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate bone marrow function and hepatic function

Exclusion Criteria

Key Exclusion Criteria:

Central nervous system (CNS) lymphoma or leptomeningeal lymphoma
Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
Treatment with any systemic anti-lymphoma therapy
Infections and allergy/hypersensitivity to study drug or excipient

The Estimated Number of Participants

  • Taiwan

    22 participants

  • Global

    478 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB