Eligibility Criteria - B-Precursor Acute-Lymphoblastic Leukaemia/Lymphoma

Please note the below criteria are a guide only and may not be an absolute contraindication to CAR-T. Eligibility will be confirmed following clinical assessment at The Alfred.

Disease characteristics

  • CD19+ B-cell acute lymphoblastic leukaemia with one of the following:
    1. Refractory
    2. Relapsed after allogeneic SCT
    3. Second or later relapse
    4. Ineligible for allogeneic SCT
  • Age 18- 25 years inclusive
  • Ph+ positive ALL who have failed 2 lines of TKI therapy or TKI is contraindicated

Patient criteria

  • WHO Performance status of < 1
  • Renal function: CrCl > 40ml/min
  •  Liver function:
    • Bilirubin < 2 x ULN (unless Gilbert’s syndrome or disease involvement)
    • ALT or ALT < 5 times the ULN for age
  • Pulmonary function: SaO2 > 91% on RA
  • Adequate haematological function (Platelets > 50x10^9 /L)
  • Cardiac function:
    • NYHA grade < 2 heart failure
    • LVEF > 40% confirmed on TTE or MUGA

Social criteria

Patients must have an appropriate full time supervising carer and be able to reside within 1 hour of The Alfred for at least the first 28 days post-CAR-T therapy (including an initial 10 to 14 day inpatient stay). Supported accommodation may be possible for patients and carers without their own accommodation option. The Novartis My CAR-T program is also accessible for any patients who reside more than 100kms from The Alfred, providing travel, accommodation and educational resources. We recommend that patients do not drive in the initial 8 weeks following CAR-T cell therapy.

Exclusion criteria

  • Pregnancy
  • HIV infection (for Kymriah)
  • Active uncontrolled Hepatitis B or C infection
  • Active CNS involvement (patients with a history of CNS involvement effectively treated are eligible excluding primary CNS lymphoma)
  • Active or poorly controlled CNS disorder (including epilepsy, dementia, or CNS involved autoimmune disorder)
  • Active uncontrolled GVHD with need for ongoing immunosuppression 
  • Comorbidities conferring an expected life expectancy of < 5 years
  • Live vaccines within 6 weeks of planned CAR-T infusion
  • Disease kinetics: anticipated acceptable performance status and organ function at time of CAR-T infusion or suitable for bridging therapy with standard available treatments
  • Complex psychosocial issues that may impact on compliance or patient safety