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
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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Infirmary Cancer Care ( Site 0157) | 36607 | Mobile | Alabama |
| Palo Verde Cancer Specialists ( Site 0105) | 85304 | Glendale | Arizona |
| Genesis Cancer and Blood Institute ( Site 0193) | 71913 | Hot Springs | Arkansas |
| Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135) | 91505 | Burbank | California |
| Medical Oncology Hematology Consultants (MOHC) ( Site 8007) | 19713 | Newark | Delaware |
| Georgetown University Medical Center ( Site 0117) | 20007 | Washington D.C. | District of Columbia |
| Mount Sinai Cancer Center ( Site 0140) | 33140 | Miami Beach | Florida |
| Mid Florida Hematology and Oncology Center ( Site 0152) | 32763 | Orange City | Florida |
| University of Chicago Medical Center ( Site 0126) | 60637 | Chicago | Illinois |
| University of Iowa-Holden Comprehensive Cancer Center ( Site 0139) | 52242 | Iowa City | Iowa |
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