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 range
65 Years – 80 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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)