Published

April 10, 2025

Lisocabtagene maraleucel [LIS01a]

Lisocabtagene maraleucel for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or high grade B-cell lymphoma or primary mediastinal large B-cell lymphoma or follicular lymphoma grade 3B either in patients who relapsed 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 have been 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 (LIS1b) can only be completed as a continuation of this first part of the form (LIS1a) and must be completed on infusion of CAR-T cells otherwise the treating Trust will not be reimbursed for the cost of lisocabtagene maraleucel

  1. This application is being made by and that leucapheresis for and treatment with lisocabtagene maraleucel-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 lymphoma and a member of the treating Trust’s lymphoma CAR-T cell multidisciplinary team.
  2. The patient is an adult (age 18 years or over) on the date of approval for lisocabtagene maraleucel by the National CAR-T Clinical Panel for lymphoma.
  3. The patient has a confirmed histological diagnosis of DLBCL or HGBCL or PMBCL or FL3B. 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
  • Primary mediastinal large B-cell lymphoma (PMBCL) or
  • Follicular lymphoma grade 3B(FL3B) 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 or
  • Transformed follicular lymphoma (TFL) to DLBCL and this diagnosis of TFL was made prior to embarking on any chemotherapy for DLBCL or
  • Transformed marginal zone lymphoma (TFL) to DLBCL and this diagnosis of transformation was made prior to embarking on any chemotherapy for DLBCL or
  • Transformed lymphoplasmacytoid lymphoma (LPL) to DLBCL and this diagnosis of transformation was made prior to embarking on any chemotherapy for DLBCL or
  • Transformation of CLL to DLBCL (Richter’s transformation) and this diagnosis of transformation was made prior to embarking on any chemotherapy for DLBCL or
  • Transformed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL) to DLBCL and this diagnosis of transformation was made prior to embarking on any chemotherapy for DLBCL or
  • Transformation of post-transplant lymphoproliferative disorder to DLBCL and EBV positive and this diagnosis of transformation was made prior to embarking on any chemotherapy for DLBCL
  • Transformation of post-transplant lymphoproliferative disorder to DLBCL type and EBV negative and this diagnosis of transformation was made prior to embarking on any chemotherapy for DLBCL Note: Patients with Burkitt lymphoma or primary CNS lymphoma are not eligible for treatment with lisocabtagene maraleucel in this indication
  1. The histological diagnosis of DLBCL or HGBCL or PMBCL or FL3B 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 a biopsy is unsafe in 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 any transformed condition 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 for DLBCL or HGBCL or PMBCL or FL3B or
  • re-biopsy has confirmed DLBCL or HGBCL or PMBCL or FL3B or
  • re-biopsy has confirmed transformed lymphoma or other condition 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 or PMBCL or FL3B.
  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 at 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 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 HGBCL or PMBCL or FL3B or transformed condition to DLBCL 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 lymphoma or other transformed conditions to DLBCL must have received the full dose 1st line anthracycline-containing standard regimen for the known DLBCL component and this regimen must have been the 1st ever chemotherapy regimen for the transformed lymphoma (e.g. patients who receive 1st line anthracycline-based chemotherapy for follicular lymphoma and then subsequently transform are not eligible for lisocabtagene in this indication). (continues on next page)

CDF funded From: 20 February 2025 - anticipated to move to NHS funding: 24 June 2025

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