A Phase 2 interventional study of Autologous CIK cell infusion in Chronic Myeloid Leukemia, sponsored by Singapore General Hospital. Completed at 1 site in Singapore. Open to participants aged 12 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-02-10.
Sponsored by Singapore General Hospital · Phase 2, Interventional, and Treatment
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-existing clinical trial targets patient with acute myeloid leukemia or MDS, and relapsed disease post allogeneic transplant.
Chronic myeloid leukemia (CML) is a disease with good response to kinase inhibitors. There are however patients in transformed phase of the disease who do not respond to these treatment. A small proportion of patients with response to Imatinib may develop mutations resulting in drug resistance. In addition, the vast majority of patients with a good response to the kinase inhibitors still have persistent CML cells detectable at a molecular level. It is known that the CML progenitors are not sensitive to the kinase inhibitors. On the other hand, immune mediated mechanism is known to be able to eradicate CML as shown by efficacy of donor lymphocyte infusion in the allogeneic transplant setting. Early clinical trials have shown clearance of bcr-abl using peptide vaccination. There is also convincing mouse data showing eradication of CML at molecular level by autologous CIK cells, but no clinical trial has been done using CIK cells for CML.
We therefore plan to expand our current CIK trial to include CML as a disease, for CML patients with various degree of response to the kinase inhibitors which have already offered its maximal effect. We aim to study whether autologous CIK cells may further improve disease response, either in the eradiation of minimal residual disease, or in conjunction with chemotherapy for control of high tumour load disease.
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 various available new drug trials, there are still some patients who will not achieve a satisfactory or sustainable response. For such patients, we aim to employ CIK cell as an immunotherapeutic modality concurrent with their original CML-specific therapy. This will enable us to explore any additional activity of CIK cells against CML without any compromise to their ongoing, established treatment.
The following groups of patients are potential candidates:
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 11 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
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Patients must understand the trial nature of this study and the additional leukapheresis procedure needed for harvesting mononuclear cells.
Exclusion Criteria:
On recruitment :
On day of infusion
4 CIK cells will be infused into patients at regular 3-weekly intervals for 4 infusions. The target cell dose per infusion is 1x10e10 CD3 cells. For patients with uncontrolled accelerated or blastic transformation undergoing chemotherapy, this will be given at the nadir of lymphopenia following chemotherapy. For other patients this will be given without interruption of the ongoing treatment with Imatinib or other kinase inhibitor.
response of CML to Cytokine induced killer cell therapy
Time frame: 6 -12 months
Sustainability of the response
Time frame: 3 years
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Singapore General Hospital