Gemtuzumab ozogamicin [GEM2]
Gemtuzumab ozogamicin as part of chemotherapy for previously untreated CD33 positive acute myeloid leukaemia CHILD patients AGED LESS THAN 15 YEARS where the following criteria are met:
- An application has been made by and the first cycle of systemic anti -cancer therapy with gemtuzumab ozogamicin will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
- The prescribing clinician is fully aware of the potential for gemtuzumab ozogamicin inducing hepatotoxicity including veno-occlusive liver disease/sinusoidal obstruction syndrome
- The patient has a confirmed diagnosis of CD33-positive acute myeloid leukaemia but does NOT have acute promyelocytic leukaemia
- The patient has previously untreated acute myeloid leukaemia
- The patient is a child* and:
- is post pubescent and less than 15 years of age
- is pre pubescent and if not going into a clinical trial will receive gemtuzumab ozogamicin at the dosage described in the results of the gemtuzumab ozogamicin COG AAML0531trial in children and reported in J Clin Oncol 2014; 32: 3021-3032 doi: 10.1200/JCO.2014.55.3628 *note there is a separate Bluteq form to be used for gemtuzumab ozogamicin in this indication in people aged 15 years and over.
- This patient has had cytogenetics performed
- The result of the cytogenetics test has shown that the patient has one of the following (please tick appropriate box): favourable risk stratification according to the 2017 ELN risk stratification OR intermediate risk stratification according to the 2017 ELN risk stratification OR in the result of the cytogenetics test was unsuccessful OR the result of the cytogenetics test is awaited and there is a clinical need for urgent systemic therapy to be commenced. If this is the case, it is mandatory that gemtuzumab ozogamicin will be discontinued as soon as cytogenetic results indicate adverse cytogenetics. Such discontinuation of gemtuzumab ozogamicin may be before all of the 1st cycle of induction treatment has been administered. Ticking the ‘Need for urgent treatment before cytogenetics known’ box is confirmation that gemtuzumab ozogamicin will be stopped as soon as adverse cytogenetics are known
- The patient is fit for intensive induction chemotherapy
- Gemtuzumab ozogamicin will only be requested by and administered in principal treatment centres.
- The use of the gemtuzumab ozogamicin has been discussed at a multi-disciplinary team (MDT) meeting which must include at least 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.
- Gemtumumab ozogamicin will be used in combination with standard induction or intensification/consolidation therapy appropriate to the age of the patient. Note for patients entered into the Myechild01 trial ,gemtuzumab ozogamicin can be given according to the trial protocol.
- Trust policy regarding unlicensed treatments has been followed as gemtuzumab ozogamicin is not licensed in this indication in children.
- Gemtuzumab ozogamicin will otherwise be used as set out in its Summary of Product Characteristics (SPC).
- The use of gemtuzumab ozogamicin is exempt from the NHS England Treatment Break policy
NHS funded From: 12 February 2019
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.