Inotuzumab ozogamicin [INO2]
The treatment of relapsed/refractory Philadelphia positive and negative B cell precursor acute lymphoblastic leukaemia in CHILD patients where all the following criteria are met:
- An application has been made by and the first cycle of systemic anti-cancer therapy with inotuzumab 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 risk factors for inotuzumab ozogamicin inducing hepatotoxicity including veno-occlusive liver disease/sinusoidal obstruction syndrome and that this risk rises as the number of cycles administered increases
- The patient has relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Please tick appropriate box as to which type of ALL the patient has: * Philadelphia chromosome negative ALL or * Philadelphia chromosome positive ALL in which case treatment with at least one second or third generation TKI must have also failed
- The patient has been previously treated with intensive combination chemotherapy as initial treatment with or without subsequent salvage chemotherapy or blinatumomab
- The patient is a child* and:
- is post pubescent or
- is pre-pubescent and will receive inotuzumab ozogamicin at the dosage described in the results of the inotuzumab ozogamicin trial in children and reported in Pediatric Blood Cancer 2014; 61: 369-372 doi: 10.1002/pbc.24721 *note there is a separate Blueteq form to be used for inotuzumab ozogamicin in this indication in adults.
- Inotuzumab ozogamicin will only be requested by and administered in principal treatment centres
- The use of the inotuzumab 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
- The patient has a performance status of 0 - 2
- The following treatment duration policy will apply to the use of inotuzumab ozogamicin: for those patients proceeding to a stem cell transplant (SCT), the recommended duration of treatment is 2 cycles. A 3rd cycle may be considered for those patients who do not achieve a complete remission (CR) or a CR with incomplete haematological recovery (CRi) and minimal residual disease negativity after 2 cycles. For patients not proceeding to a SCT, a maximum of 6 cycles of treatment may be administered. Patients who do not achieve a CR or CRi within 3 cycles should discontinue treatment
- Inotuzumab ozogamicin will be used as monotherapy
- No planned treatment breaks of more than 6 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or intercurrent comorbidities to improve).* *Requests for continuation of treatment after unplanned treatment breaks over this duration should be made via the treatment break approval process
- Trust policy regarding unlicensed treatments has been followed as inotuzumab ozogamicin is not licensed in this indication in children
- Inotuzumab ozogamicin will otherwise be used as set out in its Summary of Product Characteristics (SPC).
NHS funded From: 18 December 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.