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A Phase I Study of CD19 Specific Chimeric Antigen Receptor T-cells for Therapy of Persistent and Relapsed B-cell Leukaemia and Lymphoma Post Allogeneic Stem Cell Transplantation

ACTRN 12617001579381

Brief Summary

The aim of this project is to evaluate the Safety of Immune Cells for Patients with Relapsed Leukaemia or Lymphoma after Bone Marrow Transplant.

Intervention/Treatment

  • Stem cell transplant of CAR19 T-cells
  • Drug: Lymphodepleting cyclophosphamide
  • Drug: Fludarabine

Inclusion Criteria

  1. Any patient regardless of sex or age with persistent or recurrent disease after a matched related allogeneic stem cell transplant performed for CD19+ lymphoid malignancies. Disease may be identified by clinical examination, radiology, nuclear imaging, flow cytometry or molecular biological methods.
  2. Life expectancy greater than or equal to 6 weeks.
  3. Karnofsky/Lansky score greater than or equal to 50%, or ECOG less than or equal to 2.
  4. Donor willing and available to donate peripheral blood for the generation of CAR19 T-cells.
  5. Sexually active patients must be willing to utilise one of the more effective birth control methods for 6 months after the CTL infusion. Male partners should use a condom.
  6. Donor and patient and/or parent/guardian capable of providing informed consent.

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