Autologous Cytokine Induced Killer Cells as Adjuvant Adoptive Immunotherapy in Patients With Chronic Myeloid Leukemia on Standard Drug Therapy
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:
1. 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.
Repeated cycles of CIK will be given in phase with the planned chemotherapy cycles, to
observe for achievement of any remission and its durability.
2. 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 eg allogeneic transplant. In the absence of long term data with
Dasatinib or Nilotinib , it is justifiable to study the efficacy of addition of CIK
therapy to their baseline best response achievable with drug therapy.
3. Patients with resistance to the currently available kinase inhibitors due to T315I
mutation or other undefined mutations, with progressive relapse either at molecular,
cytogenetic or haematological level, and do not have transplant as a curative option.
In this group of patients additional of CIK to current treatment will show any activity
of CIK against the drug-resistant mutant CML cells.
4. 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. Since the role
of immunotherapy is most relevant in MRD, CIK infusion will provide the proof of
principal observation of whether imatinib-resistant CML Philadelphia stem cells can be
eradicated by these ex vivo activated and expanded cytotoxic T cells.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
response of CML to Cytokine induced killer cell therapy
6 -12 months
Yeh Ching Linn, MBBS, MRCP
Singapore General Hospital
Singapore: Domain Specific Review Boards