[M22-003]Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma

JRCT ID: jRCT2071240034

Registered date:14/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Follicular Lymphoma
• Date of first enrollment: 14/07/2024
• Target sample size: 65
• Countries of recruitment: Poland,Japan,Taiwan,Japan,Netherlands,Japan,South Korea,Japan,Australia,Japan,Italy,Japan,France,Japan,United States of America,Japan,Portugal,Japan,Germany,Japan,Spain,Japan,Israel,Japan,Czechia,Japan,Romania,Japan,Puerto Rico,Japan,Serbia,Japan,Croatia,Japan
• Study type: Interventional

Intervention(s)

-Experimental: Arm A: Epcoritamab + Lenalidomide andRituximab (R2)
Participants will receive epcoritamab in combination with R2 during the 120 week study duration.
-Experimental: Arm B: Chemoimmunotherapy (CIT) OptionA
Participants will receive CIT Option A (obinutuzumab(G) and cyclophosphamide, doxorubicin, vincristine,prednisone (CHOP) [G-CHOP]/ rituximab (R)-CHOPduring the 120 week study duration.
-Experimental: Arm B: Chemoimmunotherapy (CIT) OptionB
Participants will receive CIT Option B (G and bendamustine (Benda) [G-Benda]/R-Benda during the120 week study duration.
-Experimental: Arm C: Lenalidomide and Rituximab (R2)
Participants will receive lenalidomide and rituximab (R2) during the 120 week study duration.

Outcome(s)

Primary Outcome

1. Arm A vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)
2. Arm A vs Arm B: Number of Participants with Progression-free survival (PFS)

Secondary Outcome

1. Arm A vs Arm B: Overall Survival (OS)
2. Arm A vs Arm B: Rate of Minimal Residual Disease (MRD) Negativity Rate
3. Arm A vs Arm B: Percentage of Participants who Maintain Physical Functioning (PF) According to European
Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Diagnosis of follicular lymphoma (FL).
-Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
-Are willing and able to comply with procedures required in the protocol.
-Must have stage, II, III or IV disease.
-Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d Etude des Lymphomes Folliculaire (GELF) criteria.
-Has one or more target lesions:
A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
>=1 measurable nodal lesion (long axis>1.5cm) or >=1 measurable extra-nodal lesion (long axis>1.0 cm) on CT scan or MRI
-Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
-Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: [Arm B] at the discretion of the Investigator, and rituximab and lenalidomide (R2) [Arm C].
-Have laboratory values meeting the criteria in the protocol.

Exclude criteria

-Had major surgery within 4 weeks prior to randomization.
-Have active cytomegalovirus (CMV) disease.

Related Information

• Primary Sponsor: Satomi Natsuko
• Secondary Sponsor: Genmab K.K.
• Secondary ID(s): NCT06191744