Blinatumomab [BLI3]

The treatment of patients in first complete haematological complete remission and with minimal residual disease post 1st line induction chemotherapy in B-precursor acute lymphoblastic leukaemia in ADULT patients where all the following criteria are met:

  1. 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.
  2. The patient is an adult* *note there is a separate Bluteq form to be used for blinatumomab in this minimal residual disease indication in children.
  3. The patient has CD19 positive acute lymphoblastic leukaemia (ALL). Please indicate below whether the patient has Philadelphia negative or positive ALL:
  • Philadelphia negative ALL (use is on-label) or
  • Philadelphia positive ALL (use is off-label). By ticking this box for use in Philadelphia positive ALL, I confirm that my hospital Trust policy regarding unlicensed treatments is being followed as blinatumomab is not licensed in Philadelphia positive ALL.
  1. The patient has been previously treated with intensive 1st line combination chemotherapy as initial induction treatment.
  2. The patient is in complete haematological remission of ALL.
  3. The patient has been shown to have minimal residual disease of ≥ 0.1% (≥10-3) confirmed in a validated assay with a minimum sensitivity of 10-4. Note: a level of minimal residual disease (MRD) of less than 0.1% is not recommended by NICE and not funded.
  4. Blinatumomab will only be requested by and administered in either bone marrow transplant centres or in major haematological centres that regularly treat patients with MRD positive ALL and who have close and regular ALL multi-disciplinary team meetings and links with bone marrow transplant centres.
  5. The patient has an ECOG performance status of 0-2.
  6. 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.
  7. A maximum of 4 cycles of blinatumomab will be administered to this patient.
  8. Blinatumomab will be used as monotherapy.
  9. No planned treatment breaks of more than 4 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
  10. Blinatumomab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 22 October 2019

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CDF Managed Access: NA

NICE Technology Appraisal: TA589 (24 July 2019)

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