Eligibility and referral

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Indications for CAR T-cell treatment

Standard of care CAR T-cell therapy is approved for patients with refractory or relapsed disease indications listed under eligibility criteria. This was approved by the Medical Services Advisory Committee (MSAC) of the Australian Government.

Treatment is provided for:

  • adult patients at the Immune Effector Cell (IEC) Services at Westmead and Royal Prince Alfred Hospitals
  • paediatric patients at hospitals of the Sydney Children’s Hospital Network.

Contacts

Adult

Westmead Hospital
A/Prof Emily Blyth
Emily.Blyth@health.nsw.gov.au

WSLHD-celltherapycoordination@health.nsw.gov.au
IEC consultant on call can be contacted via switchboard on 02 8890 5555

Royal Prince Alfred Hospital
Prof P. Joy Ho
Joy.Ho1@health.nsw.gov.au
Katrina Debosz NP Katrina.Debosz@health.nsw.gov.au

Paediatric

Sydney Children’s Hospital – Randwick
A/Prof Adam Nelson
Adam.Nelson@health.nsw.gov.au
Laura Chapman
Laura.Chapman1@health.nsw.gov.au

The Children’s Hospital at Westmead
Dr Melissa Gabriel
SCHN-TCT@health.nsw.gov.au

Referral

  • Contact the IEC Service Contacts listed to discuss your patient.
  • Raise any concerns regarding your patient’s urgency, relapse status or refractory level.
  • Complete a disease specific referral form for CAR T-cell treatment for your patient. This is to confirm eligibility and obtain the clinical history of your patient.
  • For Aboriginal and Torres Strait Islander patients, please highlight with the IEC Services. The Hospital Aboriginal Liaison Officer can then link with them as early as possible.

Treatment criteria

The following treatment criteria exist. The patient must:

  • not have uncontrolled infection, including HIV or active hepatitis B or C infection
  • have a World Health Organization (WHO) performance status of 0 or 1 (or ≥70 Karnofsky/Lansky score)
  • have a condition that can be effectively managed during lymphocyte collection and manufacturing, to allow for the absence of rapidly progressive disease at the time of lymphocyte infusion.

Eligibility criteria

The eligibility criteria have been defined in the public summary documents published by Medical Services Advisory Committee (MSAC). For more information, contact the IEC Service.

Summary of eligibility criteria for CAR T-cell therapy

Disease indication

CAR T-cell

Eligibility criteria

Large B-cell Lymphoma (LBCL) including:

  • Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) [including activated B-cell (ABC) or germinal centre B-cell (GCB)]
  • DLBCL arising from follicular lymphoma (FL)
  • DLBCL associated with chronic inflammation
  • DLBCL + Epstein-Barr Virus (EBV)
  • High-grade B-cell lymphomas (HGBL) with or without MYC and BCL2 and/or BCL6 rearrangement
  • T-cell/histiocyte-rich LBCL
  • Primary cutaneous DLBCL, leg type
  • Primary mediastinal large B-cell lymphoma (PMBCL)
Axicabtagene ciloleucel (Yescarta®) ONLY

Treated in the 2nd line
CD19 Positive

Patients who are refractory to or have relapsed no more than 12 months after completion of first-line (1L) chemoimmunotherapy, including at a minimum:

  1. an anti-CD20 monoclonal antibody (unless the tumour is CD20 negative) and
  2. an anthracycline-containing regimen #

# the date of completion of chemotherapy is defined by the last date of the anthracycline containing regimen.

Diffuse large B-cell lymphoma (DLBCL)

Primary mediastinal large B-cell lymphoma (PMBCL)

Transformed follicular lymphoma (TFL)

Tisagenlecleucel (Kymriah®)

Axicabtagene ciloleucel (Yescarta®)

3rd line and beyond

Patients who are:

  • CD19 positive and
  • relapsed after autologous stem cell transplantation; or
  • have relapsed after, or be refractory to, at least two prior systemic therapies.

Mantle cell lymphoma (MCL)

Brexucabtagene autoleucel (Tecartus®)

Patients with relapsed or refractory CD19-positive mantle cell lymphoma (MCL) who have received at least two lines of therapy, including:

  • an anthracycline- or bendamustine- or cytarabine-based chemoimmunotherapy regimen that includes an anti-CD20 monoclonal antibody therapy and
  • a Bruton's tyrosine kinase (BTK) inhibitor, unless the patient is considered unsuitable for treatment with a BTK inhibitor based on predicted intolerance.

Acute lymphoblastic leukaemia (in patients ≥ 26 years of age)

Brexucabtagene autoleucel (Tecartus®)

  • CD19 positive and
  • Morphological disease in the bone marrow (>5% blasts) and
  • ≥26 years of age and
  • B-cell precursor acute lymphoblastic leukaemia that is:
    • primary refractory; or
    • first relapse if remission was 12 months or less; or
    • relapsed or refractory after two or more lines of systemic therapy; or
    • relapsed or refractory after allogeneic blood or marrow transplant.

Acute lymphoblastic leukaemia (in patients ≤25 years of age)

Tisagenlecleucel (Kymriah®)

  • CD19 positive with the absence of CD19 negative blasts and
  • ≤25 years of age (Note: the order for treatment must be placed before the patient’s 26th birthday) and
  • Weight >6kg and
  • B-cell precursor acute lymphoblastic leukaemia that is:
    • primary or secondary refractory disease and
    • in relapse post-transplant; or
    • in second or later relapse.

Note: relapse is determined by minimal residual disease (MRD) techniques using >1x10-3/0.1% as the threshold

Patients must also have sufficient organ function, including renal, hepatic, cardiac and pulmonary function. The criteria is defined on the disease-specific referral for CAR T-cells.

Other treatments and studies

The first generation of CAR T-cell treatments have focused on the B-cell antigen CD19. There are several studies worldwide looking at alternative antigens and diseases (e.g. B-cell maturation antigen in multiple myeloma). Treatments using other lymphocyte subtypes (e.g. natural killer cells) to target cancer cells are also being explored.

The current TGA approved CAR T-cell treatments are manufactured from T-cells collected from the patient (autologous). Studies are investigating the advantages of cells manufactured from a donor (allogeneic). These so called “off the shelf” products may be more accessed quickly.

Antigen specific T-cells

There are currently several studies focusing on the use of antigen specific T-cells. Researchers in NSW are leading in this area of medicine.

T-cells can be manufactured from existing blood and marrow transplant products (autologous and allogeneic) or obtained from a cell bank. Research is focused on the effectiveness of T-cells targeting individual antigens (e.g. cytomegalovirus) or a combination of antigens (e.g. multi-virus). These treatments have shown promise in treating and preventing disease. These products are available as part of clinical trials. Visit Australian Clinical Trials for more information.

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