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RECRUITING
NCT06071871
PHASE2

A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma

Sponsor: University College, London

View on ClinicalTrials.gov

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 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.

Official title: A Phase II Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

99

Start Date

2024-08-16

Completion Date

2028-07-30

Last Updated

2024-12-24

Healthy Volunteers

No

Interventions

DRUG

Glofitamab

Glofitamab is given intravenously at a dose of 2.5mg over 4 hours on Cycle 1 Day 8. Patients need to stay in hospital for 24 hours. Glofitamab is given intravenously at a dose of 10mg over 2 hours on Cycle 1 Day 15. (Patients may need to stay in hospital for 24 hours.) Glofitamab is given intravenously at a dose of 30mg over 2 hours on Day 1 of Cycles 2-12 (as relevant).

DRUG

Polatuzumab vedotin

Polatuzumab is given intravenously at a dose of 1.8mg/kg on Cycle 1 Day 2, and then Day 1 of Cycle 2-Cycle 6.

DRUG

Obinutuzumab

Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.

Locations (5)

Kings College Hospital NHS Foundation Trust

London, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Churchill Hospital

Oxford, United Kingdom