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Autologous Cytokine Induced Killer Cells as Adjuvant Adoptive Immunotherapy in Patients With Chronic Myeloid Leukemia on Standard Drug Therapy


Phase 2
12 Years
80 Years
Not Enrolling
Both
Chronic Myeloid Leukemia

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Trial Information

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.


Inclusion Criteria:



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.

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

3. Patients with resistance to genetic or haematological level, and do not have
transplant as a curative option.

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.

Patients must understand the trial nature of this study and the additional leukapheresis
procedure needed for harvesting mononuclear cells.

Exclusion Criteria:

On recruitment :

1. Renal impairment with Cr >200mmol/uL

2. Liver impairment with transaminase >5x upper limit which is not due to disease

3. Limited life expectancy <3 months

On day of infusion

1. uncontrolled infection or significant bleeding

2. unstable vital signs

3. any degree of hypoxia requiring oxygen therapy.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response of CML to Cytokine induced killer cell therapy

Outcome Time Frame:

6 -12 months

Safety Issue:

No

Principal Investigator

Yeh Ching Linn, MBBS, MRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Singapore General Hospital

Authority:

Singapore: Domain Specific Review Boards

Study ID:

CIK#3/2008

NCT ID:

NCT00815321

Start Date:

December 2008

Completion Date:

November 2011

Related Keywords:

  • Chronic Myeloid Leukemia
  • chronic myeloid leukemia
  • autologous cytokine induced killer cells
  • Chronic myeloid leukemia in blast crisis treated with chemotherapy or kinase inhibitors
  • Chronic myeloid leukemia with mutation resistant to kinase inhibitors
  • chronic myeloid leukemia with good response to kinase inhibitor and stable persistence of residual disease
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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