Status:
COMPLETED
Allogeneic Cytokine-induced Killer Immunotherapy for Relapse After Allogeneic Marrow Transplant for Haematological Malignancies
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
National Medical Research Council (NMRC), Singapore
Conditions:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
12-60 years
Phase:
PHASE1
PHASE2
Brief Summary
Cytokine-induced killer ( CIK ) cells have been shown by our lab to be cytolytic against both autologous and allogeneic acute myeloid leukemia ( AML ) cells. Large scale expansion of CIK cells has als...
Detailed Description
1. Patient inclusion criteria This trial includes only patients who have relapsed after an allogeneic transplant, who have either 1.1 No response to conventional DLI given for at least one dose, or 1....
Eligibility Criteria
Inclusion
- This trial includes only patients who have relapsed after an allogeneic transplant, who have either:
- No response to conventional DLI given for at least one dose, or
- No possibility of access to large number of donor lymphocyte for repeated doses of DLI, This applies to cases of unrelated transplant or cord blood transplant
- Patients who developed significant GVHD to conventional DLI, but had no other therapeutic option. In such cases the rationale is based on mice studies of mismatched CIK producing much less GVHD than mismatched unmanipulated splenocytes.
- In view of the period taken to culture the cell to maturity, patient must have a life expectancy of more than one month. Interim measures eg chemotherapy or conventional DLI will be given during the interval so that ongoing treatment will not be compromised in any way.
Exclusion
- Uncontrolled infection or significant bleeding
- Unstable vital signs
- Any degree of hypoxia requiring oxygen therapy.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00460694
Start Date
August 1 2006
End Date
December 1 2012
Last Update
February 10 2017
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169608