Safety of Immune Cells for Patients with Relapsed Leukaemia or Lymphoma after Bone Marrow Transplant

Phase 1

Recruiting

• Conditions: Acute Lymphoblastic Leukaemia; Chronic Lymphocytic Leukaemia; Non-Hodgkins Lymphoma; Cancer - Leukaemia - Acute leukaemia; Cancer - Leukaemia - Chronic leukaemia; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma; Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

• Registration Number: ACTRN12617001579381
• Lead Sponsor: Western Sydney Local Health District, Westmead Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-27
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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.

Exclusion Criteria

1. Uncontrolled inter-current infection.
2. Graft versus host disease greater than or equal to grade II.
3. Unmanipulated donor lymphocyte infusion within the previous 10 weeks.
4. Corticosteroid dose greater than the equivalent of 0.5mg/kg of oral prednisolone.
5. Bilirubin >2x upper limit of normal, AST >3x upper limit of normal, creatinine >2x upper limit of normal for age.
6. Pulse oximetry less than or equal to 90% on room air.
7. Pregnant or lactating.
8. History of hypersensitivity reactions to murine protein-containing products.
9. History of seizures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified