None listed
Conditions
Brief summary
This study aims to assess the safety and efficacy of combined infusion of immune cells and vaccination to boost immunity to infection after bone marrow transplantation. Who is it for? You may be eligible to join this study if you are undergoing bone marrow transplantation for any type of non-malignant condition or haematological malignancy including but not limited to acute and chronic leukaemia, myelodysplasia, non Hodgkins and Hodgkins lymphoma or myeloma. Trial details Participants in this trial will be allocated to one of three groups. The first group will receive multi-infection specific T-cells intravenously (via the vein) 28 days after bone marrow transplantation. The second group will also receive this treatment in addition to the Fluvax vaccination. The third group will undergo the immune cell infusion, Fluvax vaccination and Varivax vaccination. All participants will be assessed regularly over a period of 12 months in order to determine the safety of this treatment, and to determine whether it can prevent viral and fungal infection following allogeneic blood or marrow stem cell transplantation.
Interventions
Donor derived infection-specific T-cells (with activity against CMV, Adenovirus, EBV, VZV, Influenza, BKV and Aspergillus), 2x10^7 cells/m^2 intravenously after day+28 post transplant;
and vaccination (with Fluvax and Varivax), 0.5ml each by subcutaneous injection 24-72 hours post T-cell infusion.
3 SEQUENTIAL groups, each compared to historical controls.
1) 6 patients receiving multi-infection specific T-cells alone
2) 6 patients receiving multi-infection specific T-cells plus Fluvax
3) 6 pati
Donor derived infection-specific T-cells (with activity against CMV, Adenovirus, EBV, VZV, Influenza, BKV and Aspergillus), 2x10^7 cells/m^2 intravenously after day+28 post transplant; and vaccination (with Fluvax and Varivax), 0.5ml each by subcutaneous injection 24-72 hours post T-cell infusion. 3 SEQUENTIAL groups, each compared to historical controls. 1) 6 patients receiving multi-infection specific T-cells alone 2) 6 patients receiving multi-infection specific T-cells plus Fluvax 3) 6 patients receiving multi-infection specific T-cells plus Fluvax and Varivax
Sponsors
Professor DJ Gottlieb
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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 any type of non-malignant condition or haematological malignancy including but not limited to acute and chronic leukaemia, myelodysplasia, non Hodkgins and Hodgkins lymphoma or myeloma. 3. Recipients of peripheral blood or bone marrow stem cells. 4. Adequate hepatic and renal function (< 3 x upper limit of normal for AST (SGOT), ALT (SGPT), < 2 x upper limit of normal for total bilirubin, serum creatinine). 5. Estimated life expectancy of at least 6 months. 6. 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. Allergies to eggs or components of the Fluvax or Varivax vaccines.
Outcome results
None listed