Status:
RECRUITING
A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma
Lead Sponsor:
University College, London
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This is a phase 2, open label trial conducted in 2 parts. The overall aim is: Part 1: To determine the efficacy of Pola-Glofit as bridging treatment to CAR-T cell therapy in patients with relapsed o...
Eligibility Criteria
Inclusion
- Histologically proven CD20+ LBCL (with CD20 positivity at any timepoint) including diffuse large B cell lymphoma, high grade B cell lymphoma with MYC, BCL2 and/or BCL6 (double/triple hit lymphoma), high grade B cell lymphoma not otherwise specified (NOS), primary mediastinal B-cell lymphoma or transformed follicular lymphoma.
- Part 1: Relapsed or refractory disease and eligible for CAR T-cell therapy in the UK and in need of systemic bridging in the opinion of the local investigator.
- Part 2: Failed to achieve CMR (Deauville score 1-3) on PET scan 1-month post CAR-T or progressed at any point post CAR-T (patients in part 2 may have been previously enrolled in Part 1 and responded to Pola-Glofit bridging or be de novo patients who are naïve to this combination)
- At least one measurable target lesion
- Patient has recent archival biopsy tissue available or is willing to undergo a new biopsy.
- ECOG performance status:
- Part 1: ECOG PS 0/1
- Part 2: ECOG PS 0-2
- Life expectancy of ≥ 12 weeks
- Adequate haematological status.
- Adequate liver and renal function
- Negative test for hepatitis B, hepatitis C, HIV and SARS-CoV-2
Exclusion
- Patients with known active infection
- Current ≥ Grade 2 peripheral neuropathy
- History of confirmed progressive multifocal leukoencephalopathy
- Current evidence of CNS lymphoma
- Patients with another invasive malignancy in the last 2 years
- Significant history of cardiovascular disease
- Active autoimmune disease or immune deficiency
- Severe neurological disorder
- Uncontrolled tumour-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- Treatment with other standard anti-cancer radiotherapy/chemotherapy including investigational therapy and targeted therapy within 4 weeks prior to cycle 1 day 1
- Prior solid organ transplantation
- Prior allogeneic stem cell transplant
- Autologous SCT within 100 days prior to cycle 1 day 1
- Any history of immune related ≥ Grade 3 adverse events
- Ongoing corticosteroid use \> 25 mg/day of prednisone or equivalent within 4 weeks prior to study treatment
- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment
- Administration of a live, attenuated vaccine within 4 weeks prior to cycle 1 day 1
- History of severe allergic anaphylactic reactions to chimeric or humanised monoclonal antibodies or recombinant antibody-related fusion proteins.
- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the obinutuzumab, polatuzumab vedotin and/or glofitamab formulation.
- Known or suspected history of HLH
Key Trial Info
Start Date :
August 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2028
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06071871
Start Date
August 16 2024
End Date
July 30 2028
Last Update
December 24 2024
Active Locations (5)
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1
Kings College Hospital NHS Foundation Trust
London, United Kingdom
2
University College London Hospitals NHS Foundation Trust
London, United Kingdom
3
The Christie NHS Foundation Trust
Manchester, United Kingdom
4
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom