Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
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:
- Ifosfamide, carboplatin, etoposide, with or without rituximab
- Dexamethasone, cisplatin, cytarabine, with or without rituximab
- 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 people 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 come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
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.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
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
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information