Safety of Immune Cells for Patients with Relapsed Leukaemia or Lymphoma after Chemotherapy

Phase 1

• 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: ACTRN12619000079145
• 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: 2019-01-21
• Last Update Posted: 28 January 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Any patient regardless of sex or age with relapsed or refractory disease after standard therapy. Disease may be identified by clinical examination, radiology, nuclear imaging, flow cytometry or molecular biological methods. To qualify for enrolment, patients must have one of the following:
-Refractory CD19+ high grade NHL- defined as less than 50% reduction in lymph node size (nodes >2cm) or persisting organ enlargement or the appearance of new lymphadenopathy, hepatosplenomegaly or marrow involvement after chemotherapy or Deauville 5 PET positive disease on interim PET scan after 4 cycles of chemotherapy
- Relapsed CD19+ high grade NHL ineligible for autologous stem cell transplant or after autologous stem cell transplant
-Refractory CD19+ low grade NHL- defined as less than 50% reduction in lymph node size (nodes >2cm) or persisting organ enlargement or the appearance of new lymphadenopathy, hepatosplenomegaly or marrow involvement after chemotherapy
-Relapsed CD19+ low grade NHL less than 12 months from chemotherapy or third or greater relapse
-Refractory CLL defined as resistance to purine analogues with less than 50% reduction in lymph node size (nodes >2cm) and/or lymphocytosis, or persisting organ enlargement after initial therapy or progression/relapse requiring therapy less than 6 months post chemotherapy.
-CLL Richters transformation
-Persistent CD19+ ALL after consolidation, defined as not in CR by morphology, flow, cytogenetics or molecular methods after induction chemotherapy (includes MRD at or above threshold as assessed by flow cytometry or molecular methods)
-Relapsed CD19+ ALL as assessed by morphology, flow, cytogenetics or molecular methods at any time point during or after standard therapy

2. Karnofsky/Lansky score greater than or equal to 50%, or ECOG less than or equal to 2.
3. 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.
4. Patient and/or parent/guardian capable of providing informed consent.

Exclusion Criteria

1. Uncontrolled inter-current infection.
2. Bilirubin >2x upper limit of normal, AST >3x upper limit of normal, creatinine >2x upper limit of normal for age.
3. Pulse oximetry greater than or equal to 90% on room air.
4. Pregnant or lactating.
5. History of hypersensitivity reactions to murine protein-containing products.
6. History of seizures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified