Published

May 11, 2025

Blinatumomab [BLI2]

The treatment of relapsed/refractory Philadelphia negative B-precursor acute lymphoblastic leukaemia in CHILD patients

  1. An application has been made by and the first cycle of systemic anti-cancer therapy is to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy
  2. The patient has relapsed or refractory Philadelphia negative acute lymphoblastic leukaemia (ALL).
  3. The patient has been previously treated with intensive combination chemotherapy as initial treatment with or without subsequent salvage therapy or inotuzumab ozagamicin
  4. The patient is a child* and
  • is either post pubescent or
  • is pre pubescent and will receive blinatumomab at the dosage described in the phase 2 part of the blinatumomab trial protocol NCT01471782 and reported in J Clin Oncol 2016; 34: 4381-4389 *note there is a separate Blueteq form to be used for blinatumomab in this indication in adults.
  1. Blinatumomab should only be requested by and administered in principal treatment centres
  2. The use of the 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.
  3. The patient has a performance status of 0 - 2.
  4. A maximum of 5 cycles of treatment with blinatumomab will be administered.
  5. Blinatumomab will be used as monotherapy
  6. 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
  7. Trust policy regarding unlicensed treatments should be followed as blinatumomab is not licensed in this indication in children
  8. Blinatumomab should otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 26 September 2017

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CDF Managed Access: NA

NICE Technology Appraisal: TA450 (27 April 2017)

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