Tests zilovertamab vedotin with standard chemotherapy for previously untreated diffuse large B-cell lymphoma
Tests zilovertamab vedotin with standard chemotherapy in adults with untreated diffuse large B-cell lymphoma.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Adana, Ankara, Antalya, Istanbul, Korfez Mahallesi, and Suleymanpasa, TürkiyeSee the 8 sitesAlso in 34 other countries, 281 sites
- Trial code
- NCT06717347
- EU 2024-515566-13-00
- JRCT2061240099
- U1111-1309-3971
- Registry title
- A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,046 people, planned
- Started
- 27 Jan 2025
- Expected to end
- 29 Mar 2032
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Zilovertamab vedotin
- Rituximab
- Cyclophosphamide
- Doxorubicin
- Rituximab Biosimilar
- Prednisone
- Prednisolone
- Vincristine
- Rescue medication
- Methylprednisolone
- Record updated
- 10 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with diffuse large B-cell lymphoma (DLBCL) who have not had any treatment for it yet.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- DLBCL confirmed by a past biopsy. PET scan shows active disease (4 to 5 on the Lugano 5-point scale). Stage I disease cannot join.
- Earlier treatment
- No earlier treatment for DLBCL.
Main reasons for not taking part
- Lymphoma that changed from a slow-growing lymphoma into DLBCL
- Primary mediastinal B-cell lymphoma or Grey zone lymphoma
- Active lymphoma in the brain or spinal cord (CNS)
- Serious active heart disease
- Earlier donor tissue or solid organ transplant
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing 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
Who cannot take part
- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma
- 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 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
- 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 a history of transformation of indolent disease to DLBCL
- 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
- Known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has active infection requiring systemic therapy
- Has history of allogeneic tissue/solid organ transplant
- Has Ann Arbor Stage I DLBCL
- Has clinically significant pericardial or pleural effusion
- Has ongoing Grade >1 peripheral neuropathy
- Known active central nervous system (CNS) lymphoma
Where in Türkiye
Also in 34 other countries, 281 sites
- Baskent Universitesi Adana Dr. Turgut Noyan UAM (Site 2809)Adana, TürkiyeContact: Toll Free NumberNo longer taking part
- Ankara University Faculty of Medicine (Site 2801)Ankara, TürkiyeContact: Study CoordinatorTaking people
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi (Site 2803)Ankara, TürkiyeContact: Study CoordinatorTaking people
- Hacettepe Universite Hastaneleri (Site 2810)Ankara, TürkiyeContact: Study CoordinatorTaking people
- Antalya Egitim ve Arastirma Hastanesi (Site 2805)Antalya, TürkiyeContact: Toll Free NumberNo longer taking part
- Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi (Site 2804)Istanbul, TürkiyeContact: Study CoordinatorTaking people
- Ondokuz Mayıs Universitesi (Site 2806)Korfez Mahallesi, TürkiyeContact: Study CoordinatorTaking people
- Namık Kemal University Medical Faculty (Site 2807)Suleymanpasa, TürkiyeContact: Toll Free NumberNo longer taking part
About the trial
What the trial wants to find out
The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.
The 2 groups in the trial
- Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)Treatment being tested
Participants receive a dose of zilovertamab vedotin (1.75 mg/kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus they may receive 2 additional cycles of rituximab or biosimilar as determined by the investigator. Participants also receive 100 mg prednisone, prednisolone, or methylprednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months).
Treatment: Zilovertamab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Rituximab Biosimilar, Prednisone, Prednisolone, Rescue medication, and Methylprednisolone
- Rituximab + Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP)Existing treatment, for comparison
Participants receive 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar, 1.4 mg/m\^2 vincristine administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus they may receive 2 additional cycles of rituximab or biosimilar as determined by the investigator. Participants also receive 100 mg prednisone, prednisolone, or methylprednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months).
Treatment: Rituximab, Cyclophosphamide, Doxorubicin, Rituximab Biosimilar, Prednisone, Prednisolone, Vincristine, and Methylprednisolone
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)
- Plain-language title
- Tests zilovertamab vedotin with standard chemotherapy for previously untreated diffuse large B-cell lymphomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 10 November 2026