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RecruitingLast updated: 9 February 2024

OLYMPIA-4: This study is assessing the effectiveness and safety of immunotherapy in comparison to standard of care treatment (including chemotherapy and targeted therapy) in people with previously treated aggressive B-cell non-Hodgkin lymphomaA 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

Clinical summary

Summary

This is a randomised study that is recruiting participants with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (refractory) or has returned (relapsed).

Eligible participants will be randomised in a 1:1 ratio to one of the following arms:

Experimental Arm: Participants will receive odronextamab (bispecific antibody immunotherapy), administered by intravenous (IV) infusion

Active Comparator Arm: Participants will receive 1 of 3 standard of care salvage therapies: 

  1. Ifosfamide, carboplatin, etoposide, with or without rituximab
  2. Dexamethasone, cisplatin, cytarabine, with or without rituximab
  3. Gemcitabine, dexamethasone, cisplatin, with or without rituximab 

All active comparator arm therapies will be administered by intravenous (IV) infusion, and option for oral administration of Dexamethasone. Participants will continue with autologous stem cell transplant following a complete response/partial response.

 

Conditions

This trial is treating patients with Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

OLYMPIA-4

More information

Trial Identifiers

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Trial sponsor

Regeneron Pharmaceuticals

Scientific Title

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

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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