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Clinical Trials List

Protocol NumberR1979-HM-2299
NCT Number(ClinicalTrials.gov Identfier)NCT06230224
Active

2023-08-01 - 2029-06-30

Phase III

Not yet recruiting8

Recruiting2

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 Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Versus Standard of Care Therapy in Participants With Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (OLYMPIA-4)

  • Trial Applicant

    ICON Clinical Research Pte Ltd

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 田豐銘 Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Wei-Hong Cheng 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 Not yet recruiting

Principal Investigator 黃慈恩 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 Not yet 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 Not yet 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 Not yet recruiting

Principal Investigator 王全正 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet 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 Not yet 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 Not yet recruiting

Principal Investigator 張正雄 無
Show-Chwan Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王銘崇 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

Condition/Disease

B-Cell Non-Hodgkin Lymphoma (B-NHL)

Objectives

This trial is looking at an experimental drug called odronextamab. This trial focuses on aggressive B-cell non-Hodgkin's lymphoma in patients who have been previously treated and whose cancer has stopped responding to treatment (also called "refractory") or has come back (also called "relapsed"). tumor patients. The purpose of this trial is to understand the safety, tolerability and effectiveness of the trial drug. This trial is investigating several other research questions, including: • What side effects may occur with the investigational drug? • You test the amount of drug in your blood at different times • Whether the body has developed antibodies to the trial drug (which may make the drug less effective or may cause side effects) • The effect of the trial drug on your quality of life and ability to complete daily activities • Learn more about experimental drugs and exploratory studies in aggressive B-cell non-Hodgkin's lymphoma This trial will primarily evaluate the mode of action of odronextamab compared with usual treatment (also known as standard of care) for relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. Standard of care treatment consists of chemotherapy at the trial physician's choice, followed by an autologous stem cell transplant. An autologous stem cell transplant uses healthy blood stem cells from your own body to help your bone marrow recover from the side effects of chemotherapy. Patients enrolled in arm 1 of the trial will receive odronextamab, while patients enrolled in arm 2 will receive standard of care. Odronextamab and standard of care medicines are considered "investigational medicines" in this trial. Any treatment has risks, and clinical trials are no exception. Please consider carefully before deciding whether to participate in this trial.

Test Drug

Odronextamab (REGN1979)

Active Ingredient

Odronextamab
Odronextamab

Dosage Form

Vial

Dosage

2mg/mL
20 mg/mL

Endpoints

Comparing efficacy as defined by event-free survival (EFS) in participants who received odronextamab versus those who received standard of care (SOC)

Inclution Criteria

Inclusion Criteria:

Histologically proven aggressive B-NHL, as described in the protocol. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed.
Have primary refractory or relapse 12 months or less from initiation of frontline therapy.

Treatment at frontline should have included anti-cluster of differentiation 20 (anti-CD20) antibody and anthracycline-containing regimen.

Have measurable disease with at least one nodal lesion with longer diameter (LDi) greater than 1.5 cm or at least one extranodal lesion with LDi greater than 1.0 cm, documented by diagnostic imaging (computed tomography [CT] or magnetic resonance imaging [MRI]).
Intent to proceed to autologous stem cell transplant (ASCT).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Adequate hematologic and organ function.

Exclusion Criteria

Exclusion Criteria:

Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL, as described in the protocol.
History of or current relevant CNS pathology, as described in the protocol.
A malignancy other than NHL unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated.
Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol.
Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol.
Allergy/hypersensitivity to study drug, or excipients.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    216 participants

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