Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma (NCT05783596) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma
United States47 participantsStarted 2023-07-18
Plain-language summary
The purpose of this study is to determine how effective and safe the combination of glofitamab and obinutuzumab is in treating patients with Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) who have not received other treatments for their lymphoma.
The names of the study drugs involved in this study are:
* Glofitamab (a type of immunotherapy)
* Obinutuzumab (a type of immunotherapy)
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 confirmed diagnosis of either FL (grade 1-3A) or MZL (any subtype) with review of the diagnostic pathology specimen at one of the participating institutions. Patients with active histologic transformation are excluded.
* No prior systemic therapy for FL or MZL. Prior treatment with radiation therapy or short course steroids is allowed.
* Meets at least one criterion to begin treatment based on the modified GELF criteria:
* Symptomatic adenopathy
* Organ function impairment due to disease involvement, including cytopenias due to marrow involvement (WBC \<1.5x109/L; absolute neutrophil count \[ANC\] \<1.0x109/L, Hgb \<10g/dL; or platelets \<100x109/L)
* Constitutional symptoms
* Maximum diameter of disease \> 7cm
* \>3 nodal sites of involvement
* Risk of local compressive symptoms
* Splenomegaly (craniocaudal diameter \> 16cm on CT imaging)
* Clinically significant pleural or peritoneal effusion
* Leukemic phase (\>5x109/L circulating malignant cells)
* Rapid generalized disease progression
* Renal infiltration
* Bone lesions
* Patients cannot be in need of urgent cytoreductive chemotherapy in the opinion of the treating investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. (Appendix A)
* Age ≥18 years.
* Adequate hematologic and organ function:
* Absolute neutrophil count \> 1.0x109/L unless due to marrow involvement by lymphoma in which case ANC must be \>0.5x109/L
* Platelets …
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
End of Treatment (EOT) Complete Metabolic Response (CMR) Rate
Timeframe: (Cycle 1 = 36 days, cycle 2 - 12 = 21 days), up to 267 days