Study Comparing Zilovertamab Vedotin with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) to Polatuzumab Vedotin with R-CHP in Treating Diffuse Large B-cell Lymphoma

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT06890884

This clinical trial is exploring whether a new drug combination including zilovertamab vedotin is more effective than the current standard treatment with polatuzumab vedotin for people with a type of fast-growing blood cancer called diffuse large B-cell lymphoma (DLBCL).

Patient Parameters

Program Overview

Researchers are investigating new treatment options for a type of fast-growing blood cancer known as germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). This study aims to determine if a combination of zilovertamab vedotin and R-CHP is more effective in treating this cancer compared to the combination of polatuzumab vedotin and R-CHP.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL) based on a previous biopsy.
  • Cancer must be active and detectable on a PET scan.
  • No prior treatment for DLBCL.
  • If HIV positive, must have well-controlled HIV with antiretroviral therapy.
  • If hepatitis B positive, must have undetectable viral load with antiviral therapy.
  • If previously infected with hepatitis C, must have undetectable viral load at screening.

Exclusion Criteria

  • History of slow-growing disease transforming into DLBCL.
  • Diagnosed with primary mediastinal B-cell lymphoma or Grey zone lymphoma.
  • Diagnosed with Stage I DLBCL.
  • Significant heart problems, such as recent stroke or heart attack, unstable chest pain, heart failure, or serious heart rhythm issues.
  • Significant fluid buildup around the heart or lungs.
  • Ongoing severe nerve damage.
  • Certain genetic nerve disorders like Charcot-Marie-Tooth disease.
  • HIV positive with a history of certain cancers like Kaposi's sarcoma.
  • Currently on corticosteroid therapy.
  • Other active cancers needing treatment in the past 2 years.
  • Active cancer in the brain or spinal cord.
  • Active autoimmune disease needing treatment in the past 2 years.
  • Active infection needing treatment.
  • Active hepatitis B or C infection.
  • History of stem cell or organ transplant.

Locations

FACILITYZIPCITYSTATE
Infirmary Cancer Care ( Site 0157)36607MobileAlabama
Palo Verde Cancer Specialists ( Site 0105)85304GlendaleArizona
Genesis Cancer and Blood Institute ( Site 0193)71913Hot SpringsArkansas
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)91505BurbankCalifornia
Medical Oncology Hematology Consultants (MOHC) ( Site 8007)19713NewarkDelaware
Georgetown University Medical Center ( Site 0117)20007Washington D.C.District of Columbia
Mount Sinai Cancer Center ( Site 0140)33140Miami BeachFlorida
Mid Florida Hematology and Oncology Center ( Site 0152)32763Orange CityFlorida
University of Chicago Medical Center ( Site 0126)60637ChicagoIllinois
University of Iowa-Holden Comprehensive Cancer Center ( Site 0139)52242Iowa CityIowa

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