A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

JRCT ID: jRCT2031240247

Registered date:31/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diffuse Large B-Cell Lymphoma
• Date of first enrollment: 30/08/2024
• Target sample size: 22
• Countries of recruitment: Australia,Japan,United States of America,Japan,United Kingdom,Japan,Canada,Japan,France,Japan,Czechia,Japan,Belgium,Japan,South Korea,Japan,Hungary,Japan,Turkey,Japan,Netherlands,Japan,China,Japan,Taiwan,Japan,Greece,Japan,Mexico,Japan,Poland,Japan,Brazil,Japan,Romania,Japan,Argentina,Japan,Bulgaria,Japan,Chile,Japan,South Africa,Japan,Portugal,Japan,Singapore,Japan,Croatia,Japan,Serbia,Japan,New Zealand,Japan
• Study type: Interventional

Intervention(s)

Arm A: Epcoritamab Plus Lenalidomide (E-Len)
Participants will receive E-Len for up to 12 cycles (each cycle is 28 days).

Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx)
Participants will receive R-GemOx for up to 4 cycles (each cycle is 28 days)

Outcome(s)

Primary Outcome

- Progression-Free Survival (PFS)
PFS is defined as the duration from the date of randomization to the date of disease progression determined per Lugano 2014 criteria as assessed by an independent review committee (IRC), or death, whichever occurs first.

Secondary Outcome

- Percentage of Participants Who Achieve Complete response (CR)
CRR is defined as the percentage of participants who achieve CR determined by Lugano 2014 criteria, as assessed by an IRC that is blinded to treatment arm prior to the initiation of new anti-lymphoma therapy.
- Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
- Percentage of Participants Who Achieve Minimal Residual Disease (MRD) Negativity Rate
The MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of new anti-lymphoma therapy.

Key inclusion & exclusion criteria

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

Include criteria

- Eastern Cooperative Oncology Group Performance status score of 0 to 2.
- Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented in the most recent and representative pathology report, inclusive of the following according to the World Health Organization (WHO) 2022 as per the protocol.
- Must have relapsed or refractory (R/R) disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis.
- Participant must meet at least 1 of the following criteria:
-- Failed prior autologous stem cell transplant (ASCT), defined as relapsed after ASCT or been refractory to ASCT.
-- Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT
-- Be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) meeting at least 1 of the following criteria:
--- Unable to receive CAR-T therapy due to fitness and/or comorbidity
--- Lymphocyte apheresis failure
--- Unwilling to receive CAR-T therapy
--- Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints
--- Relapsed/progressed after having achieved at least a Partial Response (PR) or Complete Response (CR) while on prior CAR-T therapy
- Must have measurable disease
- Life expectancy > 3 months on standard of care treatment at the time of enrolling in the study

Exclude criteria

- Current evidence of primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening.
- History of prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with rituximab plus gemcitabine and oxaliplatin (R-GemOx) or gemcitabine and oxaliplatin (GemOx).
- Documented refractoriness to lenalidomide.

Related Information

• Primary Sponsor: Satomi Natsuko
• Secondary Sponsor: Genmab K.K.
• Secondary ID(s): NCT06508658