A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma (NCT06149286) — South Korea Trial Details

Condition(s) studied

Relapsed/Refractory Follicular LymphomaRelapsed/Refractory Marginal Zone Lymphoma (R/R MZL)

Investigational drug(s) / intervention(s)

Odronextamab: Administered per the protocol

Lenalidomide: Administered per the protocol

Rituximab: Administered per the protocol

Study summary

This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's Lymphoma (NHL).

This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled).

The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before.

The aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed/refractory FL and/or MZL. 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 in combination with lenalidomide
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
* The impact from the study drug on quality-of-life and ability to complete routine daily activities

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

Key Inclusion Criteria: 1. Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator, as described in the protocol. 2. Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-Cluster of Differentiation 20 (CD20) monoclonal antibody, and participant should meet indication for treatment, as described in the protocol. 3. Have measurable disease on cross sectional imaging documented by diagnostic Computed Tomography \[CT\], or Magnetic Resonance Imaging \[MRI\] imaging, as described in the protocol. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Adequate hematologic and organ function, as described in the protocol. 6. All study participants must: 1. Have an understanding that lenalidomide could have a potential teratogenic risk. 2. Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide. 3. Agree not to share study medication with another person. 4. Agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide. Key Exclusion Criteria: 1. Primary Central Nervous System (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS NHL, as described in the protocol. 2. Participants with current or past histological evidence of high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL. 3. History of or current relevant CNS pathology, as described in the protocol. 4. A malignancy other than NHL (inclusion diagnosis) unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer treated with hormone therapy or local radiotherapy (ie, pellets), cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated. 5. 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. 6. Allergy/hypersensitivity to study drugs or excipients. as described in the protocol. 7. Active infection as defined in the protocol. Note: Other protocol-defined Inclusion/Exclusion criteria apply

Primary outcome measure(s)

Incidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomide — Up to 35 days
Part 1
Incidence of Treatment Emergent Adverse Events (TEAEs) for odronextamab in combination with lenalidomide — Up to 2 years
Part 1
Severity of TEAEs for odronextamab in combination with lenalidomide — Up to 2 years
Part 1
Progression-Free Survival (PFS) as assessed by Independent Central Review (ICR) — Up to 5 years
Part 2

Trial sites (171)

Facility	City	Region	Status
David Geffen School of Medicine at UCLA	Los Angeles	California	Recruiting
Boca Raton Clinical Research (BRCR) Global	Plantation	Florida	Recruiting
Indiana University and Comprehensive Cancer Center	Indianapolis	Indiana	Recruiting
Hattiesburg Clinic	Hattiesburg	Mississippi	Recruiting
Dartmouth Cancer Center	Lebanon	New Hampshire	Recruiting
Stony Brook University Hospital	Stony Brook	New York	Recruiting
Clinical Research Alliance Inc	Westbury	New York	Withdrawn
Prohealth Care Inc	Waukesha	Wisconsin	Recruiting
Liverpool Hospital	Liverpool	New South Wales	Recruiting
Calvary Mater Newcastle	Waratah	New South Wales	Recruiting
Pindara Private Hospital	Benowa	Queensland	Recruiting
Royal Hobart Hospital	Hobart	Tasmania	Recruiting
Epworth Freemasons	East Melbourne	Victoria	Recruiting
Ordensklinikum Linz	Linz	Osterreich	Recruiting
Kepler University Hospital	Linz	Upper Austria	Recruiting
Medical University Vienna	Vienna	Austria	Recruiting
Klinikum Wels-Grieskirchen	Wels	Austria	Recruiting
Centre Hospitalier Universitaire at Universite Catholique de Louvain Namur	Yvoir	Namur	Recruiting
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital	Ghent	Oost-Vlaanderen	Recruiting
Algemeen Ziekenhuis AZ Delta	Roeselare	West-Vlaanderen	Recruiting
Ziekenhuis Netwerk Antwerpen Stuivenberg	Antwerp	Belgium	Recruiting
Institut Jules Bordet	Brussels	Belgium	Recruiting
Hospital Sao Rafael	Salvador	Estado de Bahia	Recruiting
Hospital Sirio Libanes Brasilia	Brasília	Federal District	Recruiting
Uopeccan Hospital do Cancer de Cascavel	Cascavel	Paraná	Recruiting
Hospital Erasto Gaertner	Curitiba	Paraná	Recruiting
Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul	Recruiting
Centro Gaucho Integrado	Porto Alegre	Rio Grande do Sul	Recruiting
Amaral Carvalho Hospital	Jaú	São Paulo	Recruiting
Instituto Nacional de Cancer Jose Alencar Gomes da Silva	Rio de Janeiro	Brazil	Recruiting
Hospital Sirio Libanes	São Paulo	Brazil	Recruiting
A Beneficencia Portuguesa de Sao Paulo, Oncology House	São Paulo	Brazil	Recruiting
University Hospital Hradec Kralove	Hradec Králové	East Bohemia	Recruiting
Fakultni Nemocnice Brno	Brno	Czechia	Recruiting
University Hospital Kralovske Vinohrady	Prague	Czechia	Recruiting
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia	Recruiting
Institut Paoli-Calmettes	Marseille	Bouches Du Rhone	Recruiting
CHU de Rennes	Rennes	Brittany Region	Recruiting
Centre Hospitalier Regional Universitaire de Tours	Tours	Centre-Val de Loire	Recruiting
Polyclinique Bordeaux Nord Aquitaine	Bordeaux	Gironde	Recruiting

+ 131 more sites — see the full list on the official registry below.

On this site

📄 Revlimid (lenalidomide) drug profile → 📄 Rituxan (rituximab) drug profile →

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Other trials for the same condition

A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma Active, not recruiting

A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma. Active, not recruiting