A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma (OLYMPIA-4)

Regeneron Pharmaceuticals logo

Regeneron Pharmaceuticals

Status and phase

Enrolling
Phase 3

Conditions

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

Treatments

Drug: Dexamethasone
Drug: Ifosfamide
Drug: Rituximab
Drug: Cytarabine
Drug: Carboplatin
Drug: Gemcitabine
Drug: Odronextamab
Drug: Cisplatin
Drug: Etoposide

Study type

Interventional

Funder types

Industry

Identifiers

NCT06230224
R1979-HM-2299
2022-502783-21-00 (Other Identifier)

Details and patient eligibility

About

The study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (also known as 'refractory') or has returned (also known as 'relapsed'). The aim of the study is to see how effective the study drug is compared to standard of care (SOC) therapy. The study is looking at several other research questions, including: What side effects may happen from taking the study drug versus SOC How much study drug is in your blood at different times Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) Comparing the impact from the study drug versus SOC on your quality-of-life and ability to complete routine daily activities

Enrollment

216 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

  • 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.

NOTE: Other protocol defined inclusion / exclusion criteria apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

216 participants in 2 patient groups

Odronextamab
Experimental group
Description:
Participants will receive odronextamab monotherapy.
Treatment:
Drug: Odronextamab
Standard Of Care
Active Comparator group
Description:
Participants will receive salvage therapy (ifosfamide, carboplatin, etoposide ± rituximab [ICE ± R], or dexamethasone, cisplatin, cytarabine ± rituximab [DHAP ± R], or gemcitabine, dexamethasone, cisplatin ± rituximab [GDP ± R]) and continue with autologous stem cell transplant (ASCT) following a complete response (CR)/partial response (PR).
Treatment:
Drug: Cisplatin
Drug: Etoposide
Drug: Gemcitabine
Drug: Carboplatin
Drug: Cytarabine
Drug: Rituximab
Drug: Ifosfamide
Drug: Dexamethasone

Trial contacts and locations

30

Loading...

Central trial contact

Clinical Trials Administrator

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems