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

Sponsor:	Singapore General Hospital
Collaborator:	National Medical Research Council
Information provided by:	Singapore General Hospital
ClinicalTrials.gov Identifier:	NCT00394381

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)

Group 1: As adjuvant therapy in minimal residual disease state after autologous PBSCT.
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 I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia Myelodysplastic Syndromes

U.S. FDA Resources

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 ]

Estimated Enrollment:	30
Study Start Date:	October 2006
Estimated Primary Completion Date:	December 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 :

Group 1 patients in minimal residual disease state post autologous peripheral blood stem cell transplant ( PBSCT ), and
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

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
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:

For Group 1: AML or MDS post autologous peripheral blood or marrow stem cell transplant.
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
Patients must understand the trial nature of this treatment and accept the possible absence of benefit.

Exclusion Criteria:

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

Contacts and Locations

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

Contacts

Contact: Yeh-Ching Linn, MBBS, MRCP	(65) 62223322 ext 6608	linn.yeh.ching@sgh.com.sg
Contact: Mickey Koh, MBBS, MRCP, PhD	(65) 62130602	mickey_koh@hsa.gov.sg

Locations

Singapore
Singapore General Hospital	Recruiting
Singapore, Singapore, 169608
Contact: Yeh-Ching Linn, MBBS, MRCP (65) 62223322 ext 6608 linn.yeh.ching@sgh.com.sg
Contact: Mickey Koh, MBBS, MRCP, PhD (65) 62130602 Mickey_koh@hsa.gov.sg
Sub-Investigator: Yeow Tee Goh, MBBS, M.Med
Sub-Investigator: William Hwang, MBBS, MRCP, M Med

Sponsors and Collaborators

Singapore General Hospital

National Medical Research Council

Investigators

Principal Investigator:

Yeh-Ching Linn, MBBS, MRCP

Singapore General Hospital

More Information

Publications:

Linn YC, Lau LC, Hui KM. Generation of cytokine-induced killer cells from leukaemic samples with in vitro cytotoxicity against autologous and allogeneic leukaemic blasts. Br J Haematol. 2002 Jan;116(1):78-86.

Leemhuis T, Wells S, Scheffold C, Edinger M, Negrin RS. A phase I trial of autologous cytokine-induced killer cells for the treatment of relapsed Hodgkin disease and non-Hodgkin lymphoma. Biol Blood Marrow Transplant. 2005 Mar;11(3):181-7.

Schmidt-Wolf IG, Finke S, Trojaneck B, Denkena A, Lefterova P, Schwella N, Heuft HG, Prange G, Korte M, Takeya M, Dorbic T, Neubauer A, Wittig B, Huhn D. Phase I clinical study applying autologous immunological effector cells transfected with the interleukin-2 gene in patients with metastatic renal cancer, colorectal cancer and lymphoma. Br J Cancer. 1999 Nov;81(6):1009-16.

Jiang H, Liu KY, Tong CR, Jiang B, Lu DP. [The efficacy of chemotherapy in combination with auto-cytokine-induced killer cells in acute leukemia] Zhonghua Nei Ke Za Zhi. 2005 Mar;44(3):198-201. Chinese.

Responsible Party:	Yeh-Ching Linn, 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:	June 15, 2011
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
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia

Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on February 12, 2012