Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved UKALL14 phase 1 standard induction therapy as a treatment option for the induction of remission in newly diagnosed, previously untreated adult patients with acute lymphoblastic leukaemia (ALL) patients (aged 25-65 years) treated on UKALL14-protocol. The treatment regimen notes that this is a clinical trial protocol intended for off-trial use, and that rituximab is to be included in CD20 positive patients (defined as >20% positivity). The treatment regimen also defines eligibility criteria as aged >= 25 and <= 65. years old with acute lymphoblastic leukaemia OR >= 19 and <= 65 years old with Philadelphia Chromosome Positive acute lymphoblastic leukaemia. Core treatments constituting the regimen are dexamethasone, daunorubicin, vincristine, and methotrexate, with rituximab to be included for CD20 positive patients, imatinib to be included for Philadelphia chromosome positive patients, or PEG-asparaginase for philadelphia chromosome negative patients.

This is written in the approval document as:

Induction of remission in newly diagnosed, previously untreated adult acute lymphoblastic leukaemia (ALL) patients (aged 25-65 years) treated on UKALL14-protocol.

Reimbursement

Incomplete Reimbursement

Imatinib - CDS; other drugs - N/A

Citation

UKALL14 Phase 1 Standard Induction Therapy, 2026, version number 1a, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/7011/874_UKALL14_Phase_1_Standard_Induction_Therapy.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Contributions