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

Phase 1

Completed

• Conditions: Myelodysplastic Syndrome, High Grade; Acute Myeloid Leukemia
• Interventions: Procedure: Infusion of autologous CIK cells

• Registration Number: NCT00394381
• Lead Sponsor: Singapore General Hospital

Brief Summary

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

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).

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-31
• Study First Submitted QC: 2006-10-31
• Study First Posted: 2006-11-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

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Exclusion Criteria

1. uncontrolled infection
2. life expectancy less than 6 weeks.
3. Contraindication to undergo one session of leukapheresis for PBMNC harvesting

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CIK infusion	Infusion of autologous CIK cells	Infusion of autologous CIK cells in study group. There is only one arm to this study

Primary Outcome Measures

Name	Time	Method
blood count changes	three months
T lymphocyte subsets	three months
T cell functions	3 months
adverse reactions	24 hour

Secondary Outcome Measures

Name	Time	Method
relapse rate	5 year
survival	5 year

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore