MK-2140 Plus R-CHP Versus R-CHOP for 1L DLBCL

JRCT ID: jRCT2061240099

Registered date:25/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Diffuse Large B-Cell Lymphoma
• Date of first enrollment: 07/02/2025
• Target sample size: 72
• Countries of recruitment: USA,Japan,Canada,Japan,Argentina,Japan,Brazil,Japan,Chile,Japan,Colombia,Japan,Guatemala,Japan,Mexico,Japan,Peru,Japan,Puerto Rico,Japan,Australia,Japan,Malaysia,Japan,Philippines,Japan,Singapore,Japan,South Korea,Japan,Taiwan,Japan,Thailand,Japan,China,Japan,Belgium,Japan,Denmark,Japan,France,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Refer to 7-5,Japan
• Study type: Interventional

Intervention(s)

[Arm1]MK-2140 in combination with R-CHP will be administered on Day 1 of Cycle 1, and then on Day 1 of each 3-week cycle, for up to 6 cycles. Participants with high-risk DLBCL will be allowed to receive rituximab for an additional 2 cycles. Prednisone will also be administered on Days 2 to 5 of each cycle.
[Arm2]R-CHOP (Arm 2) will be administered on Day 1 of Cycle 1, and then on Day 1 of each 3-week cycle, for up to 6 cycles. Participants with high-risk DLBCL will be allowed to receive rituximab for an additional 2 cycles. Prednisone will also be administered on Days 2 to 5 of each cycle.

Outcome(s)

• Primary Outcome: progression-free survival

Secondary Outcome

- complete response (CR) rate
- overall survival
- event-free survival
- duration of CR
- safety and tolerability
- health-related quality of life

Key inclusion & exclusion criteria

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

Include criteria

- Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues.
- Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale.
- Has received no prior treatment for their DLBCL.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization.
- Has an ejection fraction >=45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA).
- Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).
- Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization.
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.

Exclude criteria

- Has a history of transformation of indolent disease to DLBCL.
- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma.
- Has Ann Arbor Stage I DLBCL.
- Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class >=II), or serious cardiac arrhythmia requiring medication.
- Has clinically significant pericardial or pleural effusion.
- Has ongoing Grade >1 peripheral neuropathy.
- Has a demyelinating form of Charcot-Marie-Tooth disease.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has ongoing corticosteroid therapy.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Known active central nervous system (CNS) lymphoma.
- Has active autoimmune disease that has required systemic treatment in the past 2 years.
- Has active infection requiring systemic therapy.
- Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection.
- Has history of allogeneic tissue/solid organ transplant.

Related Information

• Primary Sponsor: Fujita Tomoko
• Secondary ID(s): NCT06717347