search
Back to results

Infection and Tumour Antigen Cellular Therapy (INTACT-WT1)

Primary Purpose

Leukemia, Myelocytic, Acute

Status
Unknown status
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Donor-derived WT1-CTL and P-CTL
Sponsored by
University of Sydney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Leukemia, Myelocytic, Acute

Eligibility Criteria

1 Year - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients undergoing myeloablative or non-myeloablative allogeneic transplantation from an HLA (A, B and DR) identical or 1-3 antigen mismatched family or unrelated donor
  2. Transplant performed for acute myeloid leukaemia
  3. Leukaemia blasts express the WT1 tumour antigen as determined by the European LeukaemiaNet standardised assay described in 16. 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. This assay will be performed on samples collected as part of routine clinical care at diagnosis and during initial treatment prior to transplantation. Testing will be performed after consent for trial participation has been obtained and negativity for WT1 will be classified as screening failure
  4. Recipients of peripheral blood HSCT
  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 12 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 lymphocyte antibody) given in the 4 weeks immediately prior to infusion or planned within 4 weeks 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 in other steroid preparations) administered within 72 hours prior to cell infusion
  4. Prior allogeneic HSCT
  5. Privately insured in or outpatients (see Indemnity Issues, Section 11.4)

Sites / Locations

  • Westmead HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transplant Recipient

Arm Description

The T cell product administration is personalized cellular therapy product, individually prepared for each participant. Donor-derived WT1-CTL and P-CTL. It's exact make up and effect is dependent on both donor and recipient characteristics and as such variability is expected in the response. These variations will be adjusted for by multiple samplings over time and collation and analysis of response in both individuals an the group as a whole. One infusion of 2 x 107/m2 P-CTLs prophylactically on or after day 28 post-allogeneic peripheral blood haemopoietic stem cell transplant (HSCT), combined with up to four infusions of 2x107/m2 WT1-CTLs.

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Full Information

First Posted
February 23, 2016
Last Updated
September 5, 2016
Sponsor
University of Sydney
search

1. Study Identification

Unique Protocol Identification Number
NCT02895412
Brief Title
Infection and Tumour Antigen Cellular Therapy
Acronym
INTACT-WT1
Official Title
A Clinical Trial of Donor-derived WT1 Specific T Cells for Prevention of Relapse in Combination With Multiple Pathogen Specific T Cells for Prevention of Infection in Patients Undergoing Allogeneic Haemopoietic Stem Cell Transplant for AML
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sydney

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to test a new therapy for patients with acute myeloid leukaemia who are undergoing blood stem cell transplant. In this study, the investigators will take a small number of your immune cells whose normal function is to give immunity to infections and help to fight leukaemia. These cells will be stimulated to multiply in the laboratory and will then be given to the transplant recipient after the transplant. This is a sort of "immunity transplant". The exact purpose of this study is to investigate if these cells are safe and effective in patients having a transplant for AML.
Detailed Description
The study will analyse the safety and biological efficacy of administering the investigational products (donor-derived Wilm's Tumour Antigen-specific cytotoxic T lymphocytes and with cytotoxic T lymphocytes specific for multiple opportunistic pathogens (cytomegalovirus (CMV), Adenovirus (Adv), Epstein Barr virus (EBV), Varicella-Zoster virus (VZV), Influenza, BK virus (BKV), and fungal infections), hereafter referred to as P-CTLs) for the prophylaxis of relapse, viral and fungal reactivation and infection following allogeneic blood or marrow transplantation for acute myeloid leukaemia. P-CTL will be given prophylactically a minimum of 28 days after transplantation followed by administration of monthly infusions of WT1-CTL for up to four doses. Our aims are to study the safety of combining WT1-CTL and P-CTL infusions; their persistence, effect on relapse of disease, effect on minimal residual disease, reconstitution of WT-1 and pathogen-specific immunity, viral reactivation, infection rates after transplantation, viral load; use of antiviral and antifungal pharmacotherapy for specific infections, hospitalisations and overall survival. Safety of infusions with respect to the development of adverse events within the first 12 months post-transplant will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelocytic, Acute

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transplant Recipient
Arm Type
Experimental
Arm Description
The T cell product administration is personalized cellular therapy product, individually prepared for each participant. Donor-derived WT1-CTL and P-CTL. It's exact make up and effect is dependent on both donor and recipient characteristics and as such variability is expected in the response. These variations will be adjusted for by multiple samplings over time and collation and analysis of response in both individuals an the group as a whole. One infusion of 2 x 107/m2 P-CTLs prophylactically on or after day 28 post-allogeneic peripheral blood haemopoietic stem cell transplant (HSCT), combined with up to four infusions of 2x107/m2 WT1-CTLs.
Intervention Type
Biological
Intervention Name(s)
Donor-derived WT1-CTL and P-CTL
Intervention Description
Donor-derived WT1-CTL and P-CTL. P-CTL will be given prophylactically a minimum of 28 days after transplantation followed by administration of monthly infusions of WT1-CTL for up to four doses.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients undergoing myeloablative or non-myeloablative allogeneic transplantation from an HLA (A, B and DR) identical or 1-3 antigen mismatched family or unrelated donor Transplant performed for acute myeloid leukaemia Leukaemia blasts express the WT1 tumour antigen as determined by the European LeukaemiaNet standardised assay described in 16. 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. This assay will be performed on samples collected as part of routine clinical care at diagnosis and during initial treatment prior to transplantation. Testing will be performed after consent for trial participation has been obtained and negativity for WT1 will be classified as screening failure Recipients of peripheral blood HSCT 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) Estimated life expectancy of at least 12 months Patient (or legal representative) has given informed consent Exclusion Criteria: Use of anti-lymphocyte globulin (ALG, ATG, Campath or other broad spectrum lymphocyte antibody) given in the 4 weeks immediately prior to infusion or planned within 4 weeks after infusion Grade II or greater graft versus host disease within 1 week prior to infusion Prednisone or methylprednisone at a dose of > 1 mg/kg (or equivalent in other steroid preparations) administered within 72 hours prior to cell infusion Prior allogeneic HSCT Privately insured in or outpatients (see Indemnity Issues, Section 11.4)
Facility Information:
Facility Name
Westmead Hospital
City
Westmead, Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gililan Huang
Phone
+61 2 9845 7219

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Infection and Tumour Antigen Cellular Therapy

We'll reach out to this number within 24 hrs