Combined Infusion of Immune Cells and Vaccination to Boost Immunity to Infection After Bone Marrow Transplantatio

Phase 1

• Conditions: Post haemopoietic stem cell transplant infection; Infection - Other infectious diseases; Cancer - Leukaemia - Acute leukaemia; Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

• Registration Number: ACTRN12612000800820
• Lead Sponsor: Professor DJ Gottlieb

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified