A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma (OLYMPIA-3)
R
Rita Assi
Primary Investigator
Enrolling By Invitation
18 years and older
All
Phase
3
904 participants needed
1 Location
Overview
What is the purpose of this study?
This study is researching an experimental drug called odronextamab, referred to as study
drug, when used in combination with chemotherapy. The study is focused on patients with
diffuse large B-cell lymphoma (DLBCL) that have not been treated before (called "previously
untreated"), have come back after treatment (called "relapsed"), or have not responded to
treatment (called "refractory").
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Description
What will happen during the study?
This study will be made up of Part 1a, Part 1b, and Part 2.
The aim of Part 1a and Part 1b of
the study is to see how safe and tolerable the study drug in combination with chemotherapy is
and to determine the dose and schedule of the study drug to be combined with chemotherapy in
Part 2 of the study.
The aim of Part 2 of the study is to see how effective the combination of the study drug with
chemotherapy is in comparison with the combination of rituximab and chemotherapy, the current
standard of care treatment approved for Non-Hodgkin's lymphoma (NHL). Standard of care means
the usual medication expected and used when receiving treatment for a condition.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug when combined with chemotherapy
- 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)
- The impact from the study drug on your quality of life and ability to complete routine daily activities
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Diffuse Large B-cell Lymphoma (DLBCL)
-
Age: 18 Years
-
Gender: All
KEY Inclusion Criteria:
- Previously untreated participants for lymphoma with documented cluster of differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL (Part 1A only)
- Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Life expectancy ≥ 12 months
- International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only;
- Adequate hematologic and organ function, as defined in the protocol.
KEY Exclusion Criteria:
- Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology
- Another active malignancy, significant active disease or medical condition, as described in the protocol
- Peripheral neuropathy Grade ≥3
- Treatment with any systemic anti-lymphoma therapy
- Any investigational therapy within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment
- Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
- Allergy/hypersensitivity to study drugs, as described in the protocol
- Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus disease (COVID-19) infection, uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Updated on
01 Aug 2024.
Study ID: R1979-ONC-2105, CTO-R1979-ONC-2105, 20186
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