Autologous Cytokine-induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome

This study has been completed.
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
Linn Yeh Ching, Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00394381
First received: October 31, 2006
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

A phase I/II study to explore the feasibility and efficacy of autologous CIK cells in patients with acute myeloid leukemia (AML)/ high grade myelodysplastic syndrome (MDS)

  1. Group 1: As adjuvant therapy in minimal residual disease state after autologous PBSCT.
  2. Group 2: As an adoptive immunotherapy in untreated disease state when conventional therapy with curative intent is not applicable

Condition Intervention Phase
Acute Myeloid Leukemia
Myelodysplastic Syndrome, High Grade
Procedure: Infusion of autologous CIK cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Cytokine-induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • blood count changes [ Time Frame: three months ] [ Designated as safety issue: No ]
  • T lymphocyte subsets [ Time Frame: three months ] [ Designated as safety issue: No ]
  • T cell functions [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • adverse reactions [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • relapse rate [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: October 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CIK infusion
Infusion of autologous CIK cells in study group. There is only one arm to this study
Procedure: Infusion of autologous CIK cells
Autologous CIK cells will be infused at timed intervals after autologous transplant for AML for group 1 patients, and with or without some cytoreduction treatment for group 2 patients

Detailed Description:

This is a Phase I /II study on the feasibility / efficacy of adoptive immunotherapy with autologous CIK cells for the following 2 groups of patients who have AML or high grade MDS :

  1. Group 1 patients in minimal residual disease state post autologous peripheral blood stem cell transplant ( PBSCT ), and
  2. Group 2 patients with untreated high grade MDS or AML, who are not fit for standard curative intent chemotherapy.

The CIK cells will be generated by leukapheresis from patients and cultured in GMP facilities. Four repeated infusions will be given for a target dose of 1x10e10 T cell per infusion.

Efficacy will be assessed by

  1. Disease free survival compared to historical control in group 1 given CIK cells post autologous PBSCT as adjuvant immunotherapy (n=20 over 3 years), and
  2. Effect on the peripheral or marrow leukemia cell load in group 2 patients given CIK cells as alternative therapy in place of chemotherapy (n=10).
  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. For Group 1: AML or MDS post autologous peripheral blood or marrow stem cell transplant.
  2. For Group 2: High grade MDS ( RAEB or RAEBIT ) or AML, whom the haematologist in charge has assessed and deemed unfit for chemotherapy with curative intent.Patients must have fairly stable white cell count requiring only low dose or no myelosuppressive medication
  3. Patients must understand the trial nature of this treatment and accept the possible absence of benefit.

Exclusion Criteria:

  1. uncontrolled infection
  2. life expectancy less than 6 weeks.
  3. Contraindication to undergo one session of leukapheresis for PBMNC harvesting
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394381

Locations
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
National Medical Research Council (NMRC), Singapore
Investigators
Principal Investigator: Yeh-Ching Linn, MBBS, MRCP Singapore General Hospital
  More Information

Publications:
Responsible Party: Linn Yeh Ching, Dr, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT00394381     History of Changes
Other Study ID Numbers: CIK#1/2006
Study First Received: October 31, 2006
Last Updated: May 14, 2012
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Singapore General Hospital:
acute myeloid leukemia
myelodysplastic syndrome
autologous CIK cells
autologous peripheral blood stem cell transplant

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia
Syndrome
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014