Comparing two treatments for a type of blood cancer called DLBCL

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 clinical trial aims to evaluate the effectiveness of zilovertamab vedotin combined with R-CHP against polatuzumab vedotin with R-CHP in patients diagnosed with germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). The study will assess the response rate of these treatments in patients whose cancer is PET positive. Participants must have a confirmed diagnosis of GCB DLBCL and have not received prior treatment for their condition. The trial is designed to determine if the new combination therapy leads to better outcomes compared to the standard treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (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.
* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).
* Participants 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:

The main exclusion criteria include but are not limited to the following:

* 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.
* 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 active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection.
* Has history of stem cell/solid organ transplant.

Where it's running

• Infirmary Cancer Care ( Site 0157)
  Mobile, Alabama, United States Recruiting
• Ironwood Cancer & Research Centers ( Site 0204)
  Chandler, Arizona, United States Recruiting
• Palo Verde Cancer Specialists ( Site 0105)
  Glendale, Arizona, United States Recruiting
• City of Hope - Phoenix ( Site 0202)
  Goodyear, Arizona, United States Recruiting
• Genesis Cancer and Blood Institute ( Site 0193)
  Hot Springs, Arkansas, United States Recruiting
• Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)
  Burbank, California, United States Recruiting

+98 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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• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

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• Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL

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• Polatuzumab vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in untreated DLBCL (MCD/BN2/N1)

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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.