Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02895412
Other study ID # INTACT-WT1
Secondary ID
Status Recruiting
Phase Phase 1
First received February 23, 2016
Last updated September 5, 2016
Start date August 2016
Est. completion date December 2020

Study information

Verified date September 2016
Source University of Sydney
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year to 70 Years
Eligibility 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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
Donor-derived WT1-CTL and P-CTL
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.

Locations

Country Name City State
Australia Westmead Hospital Westmead, Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2 Years Yes
See also
  Status Clinical Trial Phase
Terminated NCT00393380 - Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor Phase 2
Completed NCT01716793 - Risk-adapted Therapy for Adult Acute Myeloid Leukemia. Phase 2
Terminated NCT00152594 - Voriconazole or Placebo in the Prophylaxis of Lung Infiltrates in Patients Undergoing Induction Chemotherapy for Acute Myelogenous Leukemia Phase 3
Completed NCT01723657 - Risk Adapted Treatment for Primary Acute Myeloid Leukemia (AML) Phase 2
Recruiting NCT01034592 - Pilot Lenalidomide in Adult Diamond-Blackfan Anemia Patients w/ RBC Transfusion-Dependent Anemia N/A
Completed NCT00406393 - Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402) Phase 3
Recruiting NCT00126321 - Cladribine, Cytarabine and Idarubicin in Patients With Relapsed Acute Myelocytic Leukemia (AML) Phase 2
Recruiting NCT00449319 - AML Treatment in Untreated Adult Patients N/A
Completed NCT00186381 - Autologous Bone Marrow Transplantation in Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission Phase 2
Completed NCT00962767 - Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission Phase 3
Completed NCT01756118 - A Phase I, Dose-finding Study of BEZ235 in Adult Patients With Relapsed or Refractory Acute Leukemia Phase 1
Terminated NCT01339910 - Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or Myelodysplastic Syndrome (BMT CTN 0901) Phase 3
Completed NCT00201240 - Acute Myeloid Leukemia T Cell Depletion to Improve Transplants in Adults With Acute Myeloid Leukemia (BMT CTN 0303) Phase 2
Terminated NCT01050946 - Hematopoietic Stem Cell Transplantation (HSCT) Using CD34 Selected Mismatched Related Donor and One Umbilical Cord Unit Phase 2
Terminated NCT00446303 - A Phase II Study of Maintenance With Azacitidine in MDS Patients Phase 2
Completed NCT00044486 - Prophylaxis Trial of Posaconazole Versus Standard Azole Therapy for Neutropenic Patients (Study P01899) Phase 3
Active, not recruiting NCT02158858 - A Phase 2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis Phase 1/Phase 2
Completed NCT00286845 - Use of the MiCK Assay for Apoptosis in AML Phase 1
Completed NCT00251368 - Multicenter Study of 9-Aminocamptothecin (9-AC) in Patients With Refractory Leukemia Phase 1
Terminated NCT00048100 - Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes Phase 1