Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma (NCT06594939)

🧪 Interventions in This Study

• Polatuzumab Vedotin (DRUG)
• Mosunetuzumab (DRUG)
• Cyclophosphamide (DRUG)
• Doxorubicin (DRUG)
• Prednisone (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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.
2. 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. a. Short-course prednisone or equivalent steroid for symptom management is allowable for up to seven days.
3. 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).
4. Adequate biospecimen sample that meets current Adaptive Clonality ID Test specimen requirements for DLBCL. a. Note: the preferred ID specimen type is a formalin-fixed paraffin-embedded (FFPE) lymph node biopsy, either FFPE slides or scrolls, targeting 40 microns of material.
5. Left ventricular ejection fraction ≥50% by echocardiography or multigated acquisition (MUGA) scan.
6. Karnofsky Performance Score ≥50 or Eastern Cooperative Oncology Group (ECOG) scan 0-2.
7. Ann Arbor Stage II bulky, III, or IV disease.
8. Minimum life expectancy greater than 3 months (should be explicitly documented by the enrolling investigator).
9. Negative HIV test. Individuals with a positive HIV test at screening are eligible provided that, prior to enrollment, they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥200/µL, and have an undetectable viral load, and have not had a history of opportunistic infection attributable to acquired immunodeficiency syndrome (AIDS) within the last 12 months.
10. For patients with hepatitis B virus antigen (HBsAg) or core antibody (HBcAb) seropositivity, patients must have a negative hepatitis B viral load and an appropriate prophylaxis plan must be in place during chemotherapy therapy treatment. For all patients that are hepatitis B core antibody positive, they should take entecavir prophylaxis (0.5 mg by mouth daily) until 1 year from completion of chemotherapy. Hepatitis B viral load should be checked on these patients prior to starting chemotherapy and every 3 months thereafter if initial hepatitis B viral load is negative (±1 week if chemotherapy cycle is delayed). If hepatitis B viral load is positive, hepatology or ID referral is recommended, and hepatitis B viral load should be checked monthly and every 3 months for 12 months after end of treatment.
11. For patients with hepatitis C Ab positivity, a viral load must be checked and negative for enrollment.
12. Negative SARS-CoV-2 antigen or polymerase chain reaction (PCR) test within 7 days prior to enrollment.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Froedtert Hospital & the Medical College of Wisconsin — Milwaukee, Wisconsin

📞 Contact the Study Coordinator

Phone: (866) 680-0505

Email: cccto@mcw.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Diffuse Large B Cell Lymphoma (DLBCL)

• Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL (GRAIL) — Toronto, Ontario
• Axatilimab + CAR-T for High-Risk Lymphoma — Atlanta, Georgia
• A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma — Basking Ridge, New Jersey

Explore by condition: All Diffuse Large B Cell Lymphoma (DLBCL) clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.