Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With … (NCT06594939) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma
United States31 participantsStarted 2026-06
Plain-language summary
This single-arm, interventional phase 2 study is designed to evaluate whether the inclusion of mosunetuzumab subcutaneous and polatuzumab vedotin (Mosun-Pola) to a split-dose CHP chemotherapy backbone will improve outcomes for elderly patients with a new diagnosis of diffuse large B-cell lymphoma.
Who can participate
Age range70 Years
SexALL
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Inclusion criteria
✓. Patients aged 70-74 who are determined to be unfit or frail by the Cumulative Illness Rating Scale-Geriatric (CIRS-G) score with 5-8 comorbid conditions scored 2 or more than 1 comorbidity scored 3-4 are allowed.
✓. Newly diagnosed, untreated, biopsy-proven CD20 positive diffuse large B-cell lymphoma (DLBCL) (including high-grade B-cell lymphoma and T-cell/histiocyte-rich large B-cell lymphoma). Patients with discordant bone marrow (i.e., involved by low-grade/indolent non-Hodgkin lymphoma) are eligible. Patients with transformed DLBCL from underlying low-grade disease are eligible. Patients with composite DLBCL and concurrent low-grade lymphoma are eligible. Patients with prior treatment for low-grade NHL with non-anthracycline based regimens are eligible.
✓. Measurable disease by positron emission tomography (PET) / computed tomography (CT) using the Lugano criteria (lymph node \>1.5 cm or extranodal site \>1.0 cm).
✓. Adequate biospecimen sample that meets current Adaptive Clonality ID Test specimen requirements for DLBCL.
✓. Left ventricular ejection fraction ≥50% by echocardiography or multigated acquisition (MUGA) scan.
✓. Karnofsky Performance Score ≥50 or Eastern Cooperative Oncology Group (ECOG) scan 0-2.
✓. Ann Arbor Stage II bulky, III, or IV disease.
✓. Minimum life expectancy greater than 3 months (should be explicitly documented by the enrolling investigator).
Exclusion criteria
✕. Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy.
What they're measuring
1
Complete Response
Timeframe: Up to six months.
Trial details
NCT IDNCT06594939
SponsorMedical College of Wisconsin
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2028-06
Contact for this trial
Medical College of Wisconsin Cancer Center Clinical Trials Office