Brentuximab vedotin in combination with chemotherapy [BRE14]

For previously untreated systemic anaplastic large cell lymphoma (sALCL) CHILD patients where the following criteria are met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with brentuximab vedotin in combination with chemotherapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has a proven histological diagnosis of CD30+ve systemic anaplastic large cell lymphoma (sALCL).
  3. The patient is previously untreated for systemic anaplastic large cell lymphoma.
  4. The patient is a child* and the prescribing clinician understands that the Summary of Product Characteristics (SPC) states ‘The safety and efficacy in children less than 18 years have not yet been established.’ Please mark as to whether pre- or post-pubescent:
  • is post-pubescent
  • is pre-pubescent Please enter in the box below the patients age in years and months: ___________ *Note: there is a separate Blueteq form to be used for brentuximab in this indication in adults.
  1. The patient has not received prior treatment with brentuximab vedotin or previous cytotoxic chemotherapy. in Note: patients who present with rapidly progressing disease may receive a single course of chemotherapy, as an emergency treatment given before final diagnosis is established.
  2. the patient will be treated with brentuximab vedotin in combination with chemotherapy using the brentuximab vedotin dose (1.8mg/kg) and chemotherapy schedule described in the reference below and I understand that that the trial excluded patients less than 10Kg so brentuximab must only be given to patients who weigh 10kg or more. ‘Lowe E Reilly AF, Lim MS, Gross TG, Saguilig L, Brakasuskas D et al Brentuximab vedotin in combination with chemotherapy for pediatric patients with ALK1 ALCL: results of COG trial ANHL12P1: Blood 1 July 2021 Volume 137, Number 26,p3595-3603’
  3. The use of the brentuximab vedotin 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.
  4. The patient has an ECOG (or equivalent Karnofsky/Lansky Scale) performance status of 0 - 2.
  5. The patient does not have disease isolated to the skin, stage I disease, or central nervous system involvement.
  6. Trust policy regarding unlicensed treatments is being followed.
  7. When a treatment break of more than 6 weeks beyond the expected 3 week cycle length occurs, a treatment break approval form will be completed to restart treatment. *Requests for continuation of treatment after unplanned treatment breaks over this duration should be made via the treatment break approval process
  8. Brentuximab vedotin will otherwise be used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 03 February 2023

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA641 (12 August 2020)

Current Form Version

Important

This is an older version of the form. To view the most up to date form follow this link

Older Form Versions

There are previous versions of this form. These may not all be available on this site.