Evaluating a new treatment combination for untreated diffuse large B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness of zilovertamab vedotin combined with standard chemotherapy (R-CHP) compared to the traditional R-CHOP regimen in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Participants will be monitored for progression-free survival, which measures how long they can live without the cancer worsening. The study includes patients with confirmed DLBCL who have not received prior treatment and have specific health criteria. The goal is to determine if the new combination can improve outcomes for these patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion 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

Where it's running

• USA Mitchell Cancer Institute ( Site 0173)
  Mobile, Alabama, United States Recruiting
• Banner MD Anderson Cancer Center ( Site 0165)
  Gilbert, Arizona, United States Recruiting
• Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0167)
  Phoenix, Arizona, United States Recruiting
• The University of Arizona Cancer Center - North Campus ( Site 0124)
  Tucson, Arizona, United States Recruiting
• Providence Medical Foundation-Oncology ( Site 0168)
  Fullerton, California, United States Recruiting
• MemorialCare Health System - Long Beach Medical Center ( Site 9559)
  Long Beach, California, United States Recruiting

+238 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment for relapsed or refractory diffuse large B-cell lymphoma using zilovertamab vedotin

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• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

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• External beam radiation followed by bispecific antibody therapy for relapsed or refractory DLBCL

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.