Published

April 20, 2025

Axicabtagene ciloleucel, Axicabtagene ciloleucel [AXI02a, AXI02a]

Axicabtagene ciloleucel for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or high grade B-cell lymphoma and either in patients who relapse within 12 months of completion of 1st line chemoimmunotherapy AND who would otherwise be intended for potential stem cell transplantation or who are refractory to 1st line chemoimmunotherapy AND who would otherwise be intended for potential stem cell transplantation where the following criteria are met: This form is for the approval of leucapheresis and manufacture of CAR-T cells. There is a second part to this form which relates to the subsequent infusion of CAR-T cells and this will be available after submission of the first part. The second part of the form (AXI02b) can only be completed as a continuation of this first part of the form (AXI02a) and must be completed on infusion of CAR-T cells otherwise the treating Trust will not be reimbursed for the cost of axicabtagene ciloleucel, Axicabtagene ciloleucel for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or high grade B-cell lymphoma and either in patients who relapse within 12 months of completion of 1st line chemoimmunotherapy AND who would otherwise be intended for potential stem cell transplantation or who are refractory to 1st line chemoimmunotherapy AND who would otherwise be intended for potential stem cell transplantation where the following criteria are met: This form is for the approval of leucapheresis and manufacture of CAR-T cells. There is a second part to this form which relates to the subsequent infusion of CAR-T cells and this will be available after submission of the first part. The second part of the form (AXI02b) can only be completed as a continuation of this first part of the form (AXI02a) and must be completed on infusion of CAR-T cells otherwise the treating Trust will not be reimbursed for the cost of axicabtagene ciloleucel

  1. This application is being made by and that leucapheresis for and treatment with axicabtagene ciloleucel-modified CAR-T cells will be initiated by a consultant haematologist or medical oncologist specifically trained and accredited in the use of systemic anti-cancer therapy and working in an accredited CAR-T cell treatment centre and who is a member of the National CAR-T Clinical Panel for DLBCL and HGBCL and a member of the treating Trust’s DLBCL and HGBCL CAR-T cell multidisciplinary team.
  2. The patient is an adult (age 18 years or over) on the date of approval for axicabtagene ciloleucel by the National CAR-T Clinical Panel for DLBCL and HGBCL.
  3. The patient has a confirmed histological diagnosis of DLBCL or HGBCL. Please tick appropriately below as to which type of lymphoma the patient has:
  • Diffuse large B-cell lymphoma (DLBCL) NOS (including ABC and GCB types) or
  • High grade B-cell lymphoma (HGBCL) with or without MYC and BCL2 (double hit) and BCL6 (triple hit) re-arrangements or
  • Transformed follicular lymphoma (TFL) to DLBCL and this diagnosis of TFL was made prior to embarking on any chemotherapy for DLBCL or
  • T cell/histiocyte-rich large B-cell lymphoma or
  • Primary cutaneous DLBCL of leg type or
  • HHV8 positive DLBCL or
  • DLBCL associated with chronic inflammation or
  • EB virus positive DLBCL Note: Patients with Burkitt lymphoma or primary mediastinal B cell lymphoma or primary CNS lymphoma or Richter’s transformation to DLBCL are not eligible for treatment with axicabtagene ciloleucel in this indication.
  1. The histological diagnosis of DLBCL or HGBCL or transformed lymphoma to DLBCL has been either made by or reviewed and confirmed by a designated lymphoma stem cell transplant centre.
  2. Prior to consideration of CAR-T cell therapy the patient’s disease has been re-biopsied unless either the patient had outright progressive disease on standard 1st line chemo-immunotherapy or a biopsy is unsafe which case the patient must have progressive disease at previously known sites of active disease. In such situations the original diagnostic biopsy review is acceptable. All patients with transformed follicular lymphoma to DLBCL who fulfil criteria 6 below must have a re-biopsy and have confirmation of DLBCL histology prior to consideration of CAR-T cell therapy. Please enter appropriately below as to which scenario applies to this patient:
  • no biopsy necessary as the patient had outright progressive disease during 1st line chemo-immunotherapy or
  • re-biopsy has confirmed DLBCL or HGBCL or
  • re-biopsy has confirmed transformed follicular lymphoma to DLBCL or
  • re-biopsy is unsafe for the patient and the patient has progressive disease at previously known sites of active disease and the previous histology was DLBCL or HGBCL
  1. The patient fulfils one of the following clinical scenarios relating to these definitions of relapsed or refractory lymphoma as applied to the failure of 1st line standard chemo-immunotherapy: please tick the appropriate box below. Refractory disease is defined as progressive disease as the best response to 1st line standard chemo-immunotherapy after at least 2 cycles of chemo-immunotherapy or stable disease as the best response after least 4 cycles of 1st line standard chemo-immunotherapy or a partial response as the best response after at least 6 cycles of 1st line standard chemo-immunotherapy with biopsy-proven residual disease or a partial response with biopsy-proven progressive disease within 12 months or less from completion of treatment. Relapsed disease is defined as disease that was in complete remission following 1st line standard chemo-immunotherapy and has been followed by a biopsy-proven disease relapse within 12 months or less from completion of treatment. Progressive disease should be defined radiologically as per RECIST version 1.1 and be based on CT or MR scans and aided if necessary, after discussion at the National CAR T Clinical Panel, with the use of Lugano lymphoma response criteria. Please tick the box below which applies to this patient:
  • progressive disease after at least 2 cycles of chemo-immunotherapy as the best response to 1st line standard chemo-immunotherapy OR
  • stable disease as the best response after at least 4 cycles of 1st line standard chemo-immunotherapy with biopsy-proven residual disease OR
  • a partial response as the best response after at least 6 cycles of 1st line standard chemo-immunotherapy with biopsy-proven residual disease OR
  • a partial response to 1st line standard chemo-immunotherapy with biopsy-proven progressive disease within 12 months or less from completion of treatment OR
  • a complete response to 1st line standard chemo-immunotherapy with biopsy-proven disease relapse within 12 months or less from completion of treatment.
  1. The patient has been previously treated with a full dose 1st line anthracycline-containing standard regimen for his/her DLBCL or high grade lymphoma or with the Marietta protocol if presenting with CNS involvement. Note: acceptable anthracycline-containing regimens include R-CHOP, Pola-R-CHP, R-CODOX-M/R-IVAC, DA-EPOC-R and the Marietta protocol. Note: patients with transformed follicular lymphoma must have received the full dose 1st line anthracycline-containing standard regimen for the known DLBCL component and this regimen must have been the ever chemotherapy regimen for the transformed lymphoma (i.e. patients who receive 1st line anthracycline-based chemotherapy for follicular lymphoma and then subsequently transform are not eligible for axicabtagene in this indication).
  2. The patient has been previously treated with a regimen containing an anti-CD20 monoclonal antibody unless there is clear documentation of the determination of CD20 negative disease.
  3. On the date that the patient was confirmed as having refractory or relapsed disease according to the above definitions, the patient had only received 1st line of therapy for the DLBCL or HGBCL or TFL to DLBCL. Note: in the case of patients who have transformed from FL to DLBCL, 1st line therapy refers to the treatment of TFL to DLBCL once transformation has been documented. Note: it is recognised that some patients at the time of the demonstration of refractory or relapsed disease have very rapidly progressive disease and thus have to commence urgent 2nd line treatment. It is therefore acceptable for patients to have received a maximum of 2 cycles of standard 2nd line chemotherapy regimens with one of the following regimens (‘anticipatory bridging therapy’): R-GDP, R-GemCarbo, R-ESHAP, ICE, R-IVE, R-BendaPola and the Marietta protocol. Please enter below whether the rate of disease progression as outlined above required urgent 2nd line salvage chemotherapy (‘anticipatory bridging therapy’) in this patient:
  • no urgent chemotherapy required prior to this application or
  • a maximum of 2 cycles of one of the above standard salvage chemotherapy regimens have been given prior to this application on grounds of urgent need and all other treatment criteria on this form are fulfilled
  1. In the absence of the availability of axicabtagene ciloeucel for this 2nd line indication the patient would have been fit and intended for both standard 2nd line salvage chemotherapy (see note below) and potential stem cell transplantation. Note: Second line treatment regimens which are appropriate include: R-GDP, R-GemCarbo, R-ESHAP, R-ICE, R-IVE, R-BendaPola and the Marietta protocol.
  2. The patient has not previously been treated with an anti-CD19 antibody-drug conjugate.
  3. There is no current suspicion of CNS involvement by the lymphoma. Continued on the next page
  4. The patient has an ECOG performance score of 0 or 1. Please enter below as to the patient’s current ECOG performance status (PS): The ECOG performance status scale is as follows: PS 0 The patient is fully active and able to carry on all pre-disease performance without restriction PS 1 The patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature eg light housework, office work PS 2 The patient is ambulatory and capable of all selfcare but unable to carry out any work activities and is up and about more than 50% of waking hours PS 3 The patient is capable of only limited selfcare and is confined to bed or chair more than 50% of waking hours PS 4 The patient is completely disabled, cannot carry out any selfcare and is totally confined to bed or chair The patient currently has a performance status of either
  • ECOG PS 0 or
  • ECOG PS 1
  1. The patient has sufficient end organ function to tolerate treatment with CAR-T cell therapy.
  2. The patient has either had no previous therapy with any genetically modified autologous or allogeneic T cell immunotherapy or the patient has been treated with doses of genetically modified autologous or allogeneic T cell immunotherapy within an abandoned dosing cohort in a first in human dose-escalation phase I clinical trial. Please tick appropriate box as to which type of previous treatment the patient has had:
  • No previous therapy with any genetically modified autologous or allogeneic T cell immunotherapy or
  • Previously treated with doses of genetically modified autologous or allogeneic T cell immunotherapy within an abandoned dosing cohort in a first in human dose-escalation phase I clinical trial
  1. Prior to infusion 2 doses of tocilizumab are available for use in this patient in the event of the development of cytokine release syndrome.
  2. Axicabtagene ciloleucel-modified CAR-T cell therapy will otherwise be used as set out in its Summary of Product Characteristics (SPC).
  3. Approval for the use of axicabtagene ciloleucel has been formally given by the National DLBCL/HGBCL CAR-T cell Clinical Panel. Please state date of approval (DD/MM/YYYY)
  4. Following national approval for use of axicabtagene ciloleucel there has been local CAR-T cell multidisciplinary team agreement that this patient continues to have the necessary fitness for treatment and fulfils all of the treatment criteria listed here.

CDF funded From: 27 April 2023

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CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

Current Form Version

Note

The data on this page was produced using version 1.359 of the CDF list, downloaded from an archive of NHS England’s website on 11 April 2025 at 09:00.

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.