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

Who is this study for? Patients with Mantle Cell Lymphoma
What treatments are being studied? Acalabrutinib+Rituximab
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Men and women ≥ 60 years of age.

• Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1.

• Stage II-IV MCL and requiring treatment in the opinion of the treating clinician.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-3

• One or more of the following:

‣ Age 80 years or more

⁃ Cumulative Illness Rating Scale for Geriatrics (CIRS-G) score 6 or greater

⁃ Left ventricular ejection fraction (LVEF) less than or equal to 50% as assessed by echocardiogram

⁃ Significant co-morbidities or cardiac risk factors making anthracycline-containing chemotherapy inadvisable

⁃ Heart failure clinically determined by the presence of New York Heart Association (NYHA) failure grade II due to a cause other than MCL

⁃ Impaired respiratory function with DLCO and/or FVC/FEV1 ratio less than 75% of predicted due to a cause other than MCL

⁃ Significant respiratory illness e.g. moderate chronic obstructive pulmonary disease (COPD) bronchiectasis

⁃ Other co-morbidities that in the Investigator's opinion which would preclude the use of standard full dose immuno-chemotherapy (to be discussed on a case-by-case basis with the TMG, via UCL CTC)

• Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules/tablets without difficulty.

• Negative serum or urine pregnancy test for women of childbearing potential (WOCBP).

• Willing to comply with the contraceptive requirements of the trial.

• Written informed consent.

Locations
Other Locations
United Kingdom
The Royal Bournemouth Hospital
RECRUITING
Bournemouth
University Hospital of Wales
RECRUITING
Cardiff
Royal Cornwall Hospital
RECRUITING
Cornwall
Beatson West of Scotland Cancer Centre
RECRUITING
Glasgow
St. Bartholomew's Hospital
RECRUITING
London
University College London Hospital
RECRUITING
London
The Christie Hospital
RECRUITING
Manchester
Clatterbridge Cancer Centre
RECRUITING
Metropolitan Borough Of Wirral
Norfolk and Norwich University Hospital
RECRUITING
Norwich
Cancer and Haematology Centre, Churchill Hospital
RECRUITING
Oxford
Derriford Hospital
RECRUITING
Plymouth
Royal Stoke Hospital
RECRUITING
Stoke-on-trent
Contact Information
Primary
Max McLaughlin Callan
ctc.caramel@ucl.ac.uk
020 7679 5531
Backup
Marissa Arfan
ctc.caramel@ucl.ac.uk
020 7679 9855
Time Frame
Start Date: 2023-11-30
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 48
Treatments
Experimental: Acalabrutinib and rituximab
Patients with untreated mantle cell lymphoma will receive acalabrutinib and rituximab for up to six cycles. Each cycle will comprise of acalabrutinib 100mg twice daily orally for 28 days and rituximab 375mg/m2 IV on day 1 (+/1 3 days) of every cycle.
Sponsors
Leads: University College, London
Collaborators: AstraZeneca

This content was sourced from clinicaltrials.gov

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