Actively Recruiting
A Phase II Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma
Led by University College, London · Updated on 2024-12-24
99
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
H
Hoffmann-La Roche
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new combination of cancer drugs—glofitamab, polatuzumab vedotin, and obinutuzumab—in patients with large B-cell lymphoma (LBCL) that has come back or not responded to previous treatments. This phase 2, open-label trial aims to determine how safe and effective this drug combination is before and after CAR-T cell therapy, a specialized treatment for this type of lymphoma. The trial has two parts. In Part 1, patients receive two cycles of the drug combination as bridging treatment before CAR-T therapy. Obinutuzumab is given one week before the first dose of glofitamab. After two cycles, a PET-CT scan checks the response. If responsive and suitable, patients proceed to planned CAR-T therapy; if not, they may receive additional cycles of the drug combination and then glofitamab alone. In Part 2, patients who did not achieve complete metabolic response or progressed after CAR-T receive six cycles of the combination followed by six cycles of glofitamab. Each treatment cycle lasts 21 days, with specific dosing schedules and hospital stays for intravenous infusions. Participants will be closely monitored throughout treatment and followed up until one year after the last patient's treatment ends. Assessments include PET-CT scans and safety monitoring. Researchers measure how well the lymphoma responds to treatment, progression-free survival, overall survival, and treatment safety. The study includes detailed evaluations before, during, and after CAR-T therapy to understand the effects of the drug combination on this lymphoma type.
CONDITIONS
Brief Title
A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed CD20+ large B-cell lymphoma, including specific subtypes such as diffuse large B cell lymphoma and transformed follicular lymphoma
- For Part 1: Relapsed or refractory disease and eligible for CAR-T cell therapy requiring systemic bridging treatment
- For Part 2: Failed to achieve complete metabolic response or progressed after CAR-T therapy
- At least one measurable target lesion
- Availability of recent biopsy tissue or willingness to undergo new biopsy
- ECOG performance status 0 or 1 for Part 1, 0 to 2 for Part 2
- Life expectancy of at least 12 weeks
- Adequate blood, liver, and kidney function
- Negative tests for hepatitis B, hepatitis C, HIV, and SARS-CoV-2
You will not qualify if you...
- Known active infection
- Peripheral neuropathy grade 2 or higher
- History of progressive multifocal leukoencephalopathy
- Evidence of central nervous system lymphoma
- Another invasive cancer within the last 2 years
- Significant cardiovascular disease history
- Active autoimmune disease or immune deficiency
- Severe neurological disorder
- Uncontrolled tumor-related pain
- Uncontrolled fluid buildup such as pleural effusion, pericardial effusion, or ascites
- Recent cancer treatment including investigational therapies within 4 weeks prior to study
- Prior solid organ or allogeneic stem cell transplant
- Autologous stem cell transplant within 100 days before study
- History of severe immune-related adverse events grade 3 or above
- Use of corticosteroids above 25 mg/day prednisone or equivalent within 4 weeks before study
- Use of systemic immunosuppressive medication within 2 weeks prior to study
- Live vaccine administration within 4 weeks before study
- Severe allergic reactions to monoclonal antibodies or related products
- Known allergy to study drug components
- Known or suspected hemophagocytic lymphohistiocytosis (HLH)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles of 21 days each (up to approximately 9 months)
Participants receive treatment with Polatuzumab vedotin, Obinutuzumab, and Glofitamab in cycles lasting 21 days each. In Part 1, participants receive 2 cycles of Pola-Glofit followed by a PET-CT scan to assess response. If suitable, participants proceed to planned CAR-T therapy; otherwise, they may receive up to 4 additional cycles of Pola-Glofit and then 6 cycles of Glofitamab alone. In Part 2, participants receive 6 cycles of Pola-Glofit followed by 6 cycles of Glofitamab alone. Obinutuzumab is given before the first dose of Glofitamab. Treatment includes intravenous infusions with hospital stays as needed.
Weekly visits during each 21-day cycle with infusions on specified days; hospital stays of up to 24 hours after certain infusions
Duration - Up to 1 year post-treatment
Participants are followed for safety, disease progression, and response outcomes for up to 1 year after completing treatment.
Periodic follow-up visits as scheduled by the study team
Trial Site Locations
Total: 5 locations
1
Kings College Hospital NHS Foundation Trust
London, United Kingdom
Actively Recruiting
2
University College London Hospitals NHS Foundation Trust
London, United Kingdom
Actively Recruiting
3
The Christie NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
4
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Actively Recruiting
5
Churchill Hospital
Oxford, United Kingdom
Actively Recruiting
Research Team
P
PORTAL Trial Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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