A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma (NCT06765317) | Clinical Trial Compass
RecruitingPhase 2
A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma
United States42 participantsStarted 2025-01-16
Plain-language summary
The researchers are doing this study to find out if the study treatment is an effective treatment that causes few or mild side effects in people with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), or transformed lymphoma. The treatment being tested in this study is glofitamab, polatuzumab, and obinutuzumab in combination with standard treatment (the combination of rituximab, cyclophosphamide, doxorubicin, and prednisone, or R-miniCHP).
Who can participate
Age range65 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 65-79 years with a fitness assessment of unfit or frail per simplified GA (Appendix 1, www.filinf.it/epi)
✓. Age ≥80 years with any fitness level
✓. Pathologically confirmed DLBCL, HGBCL or transformed lymphoma
✓. No prior systemic anti-lymphoma therapy (prednisone/equivalent up to 100 mg daily x 7 days is permissible)
✓. Ann Arbor Stage 2 bulky, 3 or 4 disease (Appendix 1)
✓. Any IPI score (Appendix 1)
✓. Anthracycline eligible: LVEF ≥ 45% by echocardiogram or MUGA scan.
✓. Must have at least one bi-dimensionally measurable lesion (\>1.5 cm in its largest dimension for nodal lesions, or \>1.0 cm in its largest dimension for extranodal lesions by computerized tomography \[CT\] scan or MRI)
Exclusion criteria
✕. Prior systemic anti-lymphoma therapy (localized radiation, steroids and antibiotics are permitted)
✕. Prior solid organ transplantation
✕. Prior allogeneic stem cell transplantation
✕. Active CNS involvement
✕. Uncontrolled HIV or active HBV or HCV infection (controlled HIV with undetectable viral load and previously treated HBV and HCV are allowed) 5.1 Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing on Day 1 of every cycle and every 3 months for at least 12 months after the final cycle of study treatment and appropriate antiviral therapy as indicated.
✕.2 Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
✕. Uncontrolled active systemic infection
✕. Major surgery within 4 weeks of the first dose of study drug (exceptions may be allowed after discussion with PI if patient has fully recovered from procedure and antilymphoma therapy is urgently needed)