Published

March 7, 2025

Arsenic trioxide in combination with all- trans retinoic acid (ARTA) [ARS5]

Arsenic trioxide in combination with all- trans retinoic acid (ARTA) for the treatment of high-risk acute promyelocytic leukaemia (>=18 years old) where the following criteria are met:

  1. An application has been made by and the first cycle of arsenic trioxide will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient is aged >=18 years old and has a diagnosis of newly diagnosed high risk acute promyelocytic leukaemia (APML) as confirmed by: 9 • a white cell count >=10,000/µl (or 10 x 10 /L) AND • fusion of the PML/RARa gene (confirmed by fluorescence in situ hybridisation (FISH) analysis or PCR
  3. The patient does not meet any of the following exclusion criteria: • patient with isolated myeloid sarcoma but without evidence of APL by bone marrow or peripheral blood morphology • patients with a pre-existing diagnosis of a prolonged QT syndrome, a history or presence of significant ventricular or atrial tachyarrhythmia, right bundle branch block plus left anterior hemiblock, bifascicular block • patients on active dialysis for renal dysfunction • female patients who are pregnant • hypersensitivity to arsenic trioxide or ATRA
  4. The use of the arsenic trioxide will be discussed at a multi-disciplinary team (MDT) meeting which must include at least two haematology consultants.
  5. The patient will receive the recommended dose and treatment regimen for arsenic trioxide as suggested in the NHS England Clinical Commissioning Policy.
  6. The stopping / exit criteria have been explained and agreed with the patient and/or carer before the treatment is started and this has been documented in the patient records.
  7. The Trust policy regarding unlicensed treatments has been followed. NB. The use of arsenic trioxide in this indication is off-label, therefore Trust policy regarding unlicensed medicines should apply.
  8. The patient has not previously received arsenic trioxide.
  9. Arsenic trioxide will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 05 March 2025

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CDF Managed Access: NA

NICE Technology Appraisal: NHSE Policy: URN2320 (NA)

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