Arsenic trioxide [ARS3]
Arsenic trioxide for treating newly diagnosed low to intermediate risk acute promyelocytic leukaemia in CHILDREN where the following criteria are met:
- 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
- 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
- The patient is newly diagnosed with acute promyelocytic leukaemia
- The patient has low to intermediate risk acute promyelocytic leukaemia (white cell count ≤10 x 10⁹/L) and has not received any chemotherapy for this. Patients with high risk acute promyelocytic leukaemia are not funded for treatment with arsenic trioxide
- The patient will be treated with induction treatment of arsenic trioxide in combination with all-trans-retinoic acid (ATRA)
- Induction treatment with arsenic trioxide will be continued until complete remission is achieved but if complete remission is not achieved by day 60, arsenic trioxide will be discontinued
- As consolidation therapy, a maximum of 4 cycles of arsenic trioxide will be prescribed, each cycle being 4 weeks on treatment followed by 4 weeks off therapy
- 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 trial as reported in Lancet Oncology 2015; 16: 1295-1305.
- 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
- The hospital Trust policy regarding unlicensed treatments has been followed as arsenic trioxide is not licensed in this indication in children
- 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
- Arsenic trioxide is to be otherwise used as set out in its SPC
NHS funded From: 11 September 2018
Additional information
Current Form Version
Note
The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.
If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.