Arsenic trioxide [ARS4]

Arsenic trioxide for treating relapsed/refractory acute promyelocytic leukaemia in CHILDREN where the following criteria have been met:

  1. An application is made by and the start of systemic anti-cancer therapy with 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 a CHILD and has a confirmed diagnosis of acute promyelocytic leukaemia characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor- alpha (PML/RAR-alpha) gene
  3. The patient has acute promyelocytic leukaemia which is EITHER refractory to or relapsed after previous treatment which included a retinoid and chemotherapy OR has relapsed after a complete remission which lasted at least 2 years following previous arsenic trioxide and all-trans-retinoic acid treatment
  4. The patient will be treated with induction and consolidation treatment of arsenic trioxide in combination with all-trans-retinoic acid (ATRA) As combination therapy with ATRA is unlicensed in this relapsed/refractory setting, hospital Trust policy regarding unlicensed treatments should be followed
  5. Induction treatment with arsenic trioxide will be continued until complete remission is achieved but if complete remission is not achieved by day 50 if the dosing and schedule is used as in the Summary of Product Characteristics or by day 60 if the UK NCRI AML 17 protocol is used (Lancet Oncology 2015; 16: 1295-1305), arsenic trioxide will be discontinued
  6. As consolidation therapy, either the dosing and schedule in the Summary of Product Characteristics is used for a maximum of 5 weeks or the dosing and scheduling of the UK NCRI AML17 protocol (Lancet Oncology 2015; 16: 1295-1305) is used for a maximum of 4 cycles of arsenic trioxide, each cycle being 4 weeks on treatment followed by 4 weeks off therapy
  7. The patient is a pre-pubescent or post-pubescent child and will be treated with the dosing and schedule of administration of arsenic trioxide either in accordance with that described in the Summary of Product Characteristics (SPC) or that used in the UK NCRI AML17 protocol as reported in Lancet Oncology 2015; 16: 1295-1305.
  8. The use of arsenic trioxide has been discussed at a multi-disciplinary team (MDT) meeting which must include two consultants in the subspecialty with active and credible expertise in the relevant field of whom at least one must be a consultant paediatrician. The MDT should include a paediatric pharmacist and other professional groups appropriate to the disease area
  9. The hospital Trust policy regarding unlicensed treatments has been followed as arsenic trioxide is not licensed in this indication in children
  10. The treating team is aware of the risk of and the treatment for * APL differentiation syndrome * QT interval prolongation and the need for monitoring of electrolytes * Liver toxicity Arsenic trioxide is excluded from the NHS England Treatment Break Policy
  11. Arsenic trioxide is to be otherwise used as set out in its SPC.

[NHS funded]{.badge .rounded-pill .bg-success} From: 11 September 2018

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NICE Technology Appraisal: TA526 (13 June 2018)

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