Status:
COMPLETED
Autologous Cytokine Induced Killer Cells (CIK) for Chronic Myeloid Leukemia (CML) Patients on Standard Drug Therapy
Lead Sponsor:
Singapore General Hospital
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
12-80 years
Phase:
PHASE2
Brief Summary
This is an extension of our ongoing clinical trial using ex vivo expanded autologous Cytokine-induced killer (CIK) cells as an adoptive cellular immunotherapy for haematological malignancies. The pre-...
Detailed Description
Patients with CML falls into various groups based on their disease stage and response to kinase inhibitors. In the context of currently available kinase inhibitors, allogeneic transplant and the vario...
Eligibility Criteria
Inclusion
- Blast crisis / accelerated phase patients who have failed to response to the kinase inhibitors but are fit to undergo induction chemotherapy as for the acute leukemia.
- Blast crisis / accelerated phase patients who have achieved a haematological or cytogenetic response to the kinase inhibitors, but do not have further definitive curative options
- Patients with resistance to genetic or haematological level, and do not have transplant as a curative option.
- Patients who have achieved a stable but residual molecular evidence of CML, who are willing to explore additional means with a hope to eradication of MRD.
- Patients must understand the trial nature of this study and the additional leukapheresis procedure needed for harvesting mononuclear cells.
Exclusion
- On recruitment :
- Renal impairment with Cr \>200mmol/uL
- Liver impairment with transaminase \>5x upper limit which is not due to disease
- Limited life expectancy \<3 months
- On day of infusion
- uncontrolled infection or significant bleeding
- unstable vital signs
- any degree of hypoxia requiring oxygen therapy.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00815321
Start Date
December 1 2008
End Date
November 1 2011
Last Update
February 10 2017
Active Locations (1)
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1
Dept of Haematology, Singapore General Hospital
Singapore, Singapore, 169608