Actively Recruiting
A 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
206 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
The PORTAL study will test a new combination of drugs (glofitamab, polatuzumab vedotin and obinutuzumab) in patients with large B-cell lymphoma (LBCL) that has come back (relapsed) or not responded to previous treatment. It will determine how safe and effective the combination of these cancer drugs is in treating LBCL before and after CAR-T cell therapy.
CONDITIONS
Official 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 proven CD20+ large B-cell lymphoma including diffuse large B cell lymphoma, high grade B cell lymphoma with MYC, BCL2 and/or BCL6, primary mediastinal B-cell lymphoma, or transformed follicular lymphoma
- For Part 1: Relapsed or refractory disease and eligible for CAR T-cell therapy in the UK needing systemic bridging
- For Part 2: Failed to achieve complete metabolic response or progressed after CAR-T cell therapy
- At least one measurable target lesion
- Availability of recent biopsy tissue or willingness to undergo a 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 test for hepatitis B, hepatitis C, HIV, and SARS-CoV-2
You will not qualify if you...
- Known active infection
- Peripheral neuropathy of grade 2 or higher
- History of progressive multifocal leukoencephalopathy
- Evidence of central nervous system lymphoma
- Another invasive cancer within the past 2 years
- Significant cardiovascular disease
- Active autoimmune disease or immune deficiency
- Severe neurological disorder
- Uncontrolled tumor-related pain
- Uncontrolled pleural, pericardial effusion, or ascites
- Recent anti-cancer treatment or investigational therapy within 4 weeks before study
- Prior solid organ or allogeneic stem cell transplant
- Autologous stem cell transplant within 100 days before study
- History of immune-related severe adverse events grade 3 or higher
- Ongoing corticosteroid use above 25 mg/day prednisone or equivalent within 4 weeks prior
- Use of systemic immunosuppressive medication within 2 weeks prior
- Live attenuated vaccine within 4 weeks prior
- Severe allergic reactions to monoclonal antibodies
- Known allergy to study drug components
- Known or suspected history of hemophagocytic lymphohistiocytosis
AI-Screening
AI-Powered Screening
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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
CONTACT
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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