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