A Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refracto… (NCT06213311) | Clinical Trial Compass
RecruitingPhase 2
A Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma
United States40 participantsStarted 2024-05-07
Plain-language summary
To learn if the combination of axicabtagene ciloleucel (axi-cel) and glofitamab as first-line therapy in high-risk LBCL participants or as second-line therapy in LBCL participants can help to control the disease.
Who can participate
Age range
18 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:
* Histologically proven CD19- and CD20-positive LBCL, including transformation from indolent lymphomas.
* Have disease that is refractory to or relapsed \<=12 months after the completion of first-line chemoimmunotherapy
• Refractory disease defined as no complete response (CR) to first-line therapy; participants who are intolerant to first-line therapy are excluded
* Progressive disease (PD) as best response to first-line therapy
* Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP)
* Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease or disease progression ≤ 12 months from completion of therapy
• Relapsed disease defined as CR to first-line therapy followed by biopsy- proven disease relapse ≤ 12 months of completing first-line therapy.
* Participants must have received first-line therapy including:
* Anti-CD20 monoclonal antibody
* An anthracycline containing chemotherapy regimen
* Age 18 or older
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
* Participants must be willing and able to comply with protocol-mandated hospitalization upon administration of the first dose of glofitamab.
* Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:
* Absolute neutrophil count ≥ 1000/μL
* Platelet count either ≥ 75,000/μL or \>50K if documented lymphomatous involvement of bone marrow
* Absolute…
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.
What they're measuring
1
Safety and adverse events (AEs)
Timeframe: Through study completion; an average of 1 year