TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-c⦠(NCT07502872) | Clinical Trial Compass
Not Yet RecruitingPhase 2
TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma
United States30 participantsStarted 2026-05-01
Plain-language summary
This is a single-center, phase 2, open-label clinical trial of a novel combination of polatuzumab vedotin, glofitamab, and tafasitamab (TPG) as first-line treatment of patients with diffuse large B cell lymphoma (DLBCL) or high-grade B cell lymphoma (HGBL).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures.
ā. Age ā„18 years.
ā. Histologically confirmed diagnosis of DLBCL, or HGBL, according to 5th edition WHO classification. Eligible WHO entities include:
ā. FDG-avid disease by PET-CT Lugano criteria.
ā. No prior systemic therapy for B-cell lymphoma, except for:
ā. Performance status ECOG 0, 1, or 2.
ā. Ability to receive one of the standard chemotherapy regimens for DLBCL/HGBL including attenuated versions, where clinically appropriate
ā. Required initial laboratory values: (unless due to underlying lymphoma):
Exclusion criteria
ā. Pregnancy, breast-feeding, or prisoner status.
ā. Central nervous system involvement by the lymphoma.
ā. Prior solid organ transplantation or allogeneic stem cell transplantation.
ā. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.
ā. Known NYHA class 3/4 congestive heart failure, left ventricular ejection fraction (LVEF) \<30%, or active ischemic heart disease.
What they're measuring
1
Complete response rate
Timeframe: 3 months after starting therapy
2
Rate of toxicities
Timeframe: From the day when informed consent is obtained until 90 days following the last administration of study treatment.
ā. Use of systemic immunosuppressive medications (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 2 weeks prior to first dose of study treatment (except as allowed in the inclusion criteria for the management of lymphoma).