ACTRN12618001090202
Recruiting
Phase 1
Coadministration of Malignancy and Infection specific T cells after allogeneic stem cell Transplant for Acute Leukaemia with CD34+ selected stem cells
Western Sydney Local Health District, Westmead Hospital0 sites20 target enrollmentJune 29, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Western Sydney Local Health District, Westmead Hospital
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients aged 1\-69 years undergoing first myeloablative or non\-myeloablative allogeneic transplantation from an HLA identical family or 10 out of 10 HLA matched (A, B, C, DRB1, DQB1\) unrelated donor
- •2\. Transplant performed for acute myeloid leukaemia or acute lymphoblastic leukemia in morphological first complete remission
- •3\. For AML, where diagnosis or relapse samples are available, leukaemia blasts express the WT1 tumour antigen as determined by the European LeukaemiaNet standardised assay described in Candoni (et al.) 2009\. WT1 overexpression will be defined by greater than 250 copies/104ABL copies in bone marrow samples or greater than 50 copies/104ABL copies in peripheral blood. For ALL, leukemia blasts express the CD19 antigen
- •4\. Recipients of peripheral blood or bone marrow stem cells
- •5\. Adequate hepatic and renal function (\< 3 x upper limit of normal for AST, ALT, \< 2 x upper limit of normal for total bilirubin, serum creatinine)
- •6\. Estimated life expectancy of at least 6 months
- •7\. Patient (or legal representative) has given informed consent
Exclusion Criteria
- •1\. Use of anti\-lymphocyte globulin (ALG, ATG, Campath or other broad spectrum anti\-lymphocyte antibody) given in the 28 days immediately prior to malignancy or infection specific T cell infusion (MITI) or planned within 28 days after infusion
- •2\. Grade II or greater graft versus host disease within 1 week prior to infusion
- •3\. Prednisone or methylprednisone at a dose of \> 1 mg/kg (or equivalent) administered within 2 days prior to T cell infusion
- •4\. Intercurrent medical, surgical or psychiatric condition which may interfere with the conduct or safety of the trial
- •5\. Patients taking anti\-viral or anti\-fungal medication for CMV or proven or probable Aspergillus infection at the time of commencement of transplant conditioning
- •6\. Previous unmanipulated donor lymphocyte infusion after transplant
- •7\. Prior history of seizures if undergoing transplant for ALL
- •8\. Privately insured in or outpatients (see Indemnity Issues, Section 11\.4
Outcomes
Primary Outcomes
Not specified
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