Blinatumomab [BLI4]
The treatment of patients in first complete haematological remission and with minimal residual disease post 1st line induction chemotherapy in B-precursor acute lymphoblastic leukaemia in CHILD patients where all the following criteria have been met:
- This application has been made by and the first cycle of systemic anti -cancer therapy with blinatumomab 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 please mark as to whether pre- or post-pubescent:
- is post-pubescent or
- is pre-pubescent and will receive blinatumomab at the paediatric dosage described in the blinatumomab summary of product characteristics (SmPC). *note there is a separate Blueteq form to be used for blinatumomab in this indication in adults.
- The patient has CD19 positive acute lymphoblastic leukaemia (ALL). Please indicate below whether the patient has Philadelphia negative or positive ALL:
- Philadelphia negative ALL or
- Philadelphia positive ALL
- The patient has been previously treated with 1st line intensive combination chemotherapy as initial induction treatment.
- The patient is in complete haematological remission of ALL. 4
- The patient’s bone marrow has been shown to have minimal residual disease level of ≥ 0.01% (≥10- ) confirmed in a validated assay. Note: a patient who has minimal residual disease (MRD) negativity defined as being less than 0.01% is potentially eligible for blinatumomab as part of consolidation therapy via form BLI6.
- The first cycle of blinatumomab will only be requested by, prescribed, and commenced in Principal Treatment Centres (PTCs). Subsequent cycles (including the latter parts of the first 28-day treatment cycle) of blinatumomab may be administered at the PTC or in partnership with enhanced POSCUs under the direction of the PTCs and in agreement with relevant Operational Delivery Networks.
- The patient has a Karnofsky/Lansky performance score of 60 or more.
- The patient will be treated with 1 cycle of induction blinatumomab and the potential benefits and risks associated with continued treatment after the 1st cycle of blinatumomab in patients who do not show haematological benefit will be assessed.
- A maximum of 4 cycles of treatment with blinatumomab will be administered.
- Blinatumomab will be used as systemic monotherapy. Note: any intrathecal chemotherapy may be continued as planned during any blinatumomab cycles.
- Blinatumomab 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.
- When a treatment break of more than 6 weeks beyond the expected cycle length is needed, I will complete a treatment break approval form to restart treatment.
- Trust policy regarding unlicensed treatments has been followed as blinatumomab is not licensed in this indication in children.
- Blinatumomab will otherwise be used as set out in its Summary of Product Characteristics (SPC).
NHS funded From: 22 October 2019
Additional information
Current Form Version
Note
The data on this page was produced using version 1.367 of the CDF list, downloaded from NHS England’s website on 27 June 2025 at 18:00.
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.