RecruitingPhase 2NCT05004064

Acalabrutinib and Rituximab in Previously Untreated Mantle Cell Lymphoma

Phase II Study of Acalabrutinib and Rituximab for Elderly or Frail Patients With Previously Untreated Mantle Cell Lymphoma


Sponsor

University College, London

Enrollment

48 participants

Start Date

Nov 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase II, single-arm, open-label, multicentre study of acalabrutinib and rituximab for elderly or frail patients with previously untreated mantle cell lymphoma.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — acalabrutinib (a targeted therapy) and rituximab (an antibody therapy) — as a first-time treatment for older or frailer patients with Mantle Cell Lymphoma (MCL), a type of blood cancer, who may not be able to tolerate more intensive chemotherapy. **You may be eligible if...** - You are 60 years of age or older with a confirmed diagnosis of Mantle Cell Lymphoma - You have Stage II–IV disease that requires treatment - You are older (80+), have multiple other health conditions, or have heart problems that make standard intensive chemotherapy too risky - You have not previously been treated for MCL **You may NOT be eligible if...** - You are younger than 60 - You have already received treatment for MCL - You are otherwise fit enough for standard intensive chemotherapy (unless you opt for this milder approach) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcalabrutinib

Patients will receive acalabrutinib 100mg twice daily for up to six 28 day cycles. Patients can receive 100mg once daily for cycle 1, day 1 to day 7, according to the investigator's discretion.

DRUGRituximab

Patient will receive rituximab 375 mg/m2 IV on day 1 (+/- 3 days) of each cycle, for a maximum of 6 cycles


Locations(12)

The Royal Bournemouth Hospital

Bournemouth, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Royal Cornwall Hospital

Cornwall, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

St. Bartholomew's Hospital

London, United Kingdom

University College London Hospital

London, United Kingdom

The Christie Hospital

Manchester, United Kingdom

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Cancer and Haematology Centre, Churchill Hospital

Oxford, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

Royal Stoke Hospital

Stoke-on-Trent, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05004064


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