NCT00394381

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2006

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

5.3 years

First QC Date

October 31, 2006

Last Update Submit

February 9, 2017

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndrome, High Grade

Keywords

acute myeloid leukemiamyelodysplastic syndromeautologous CIK cellsautologous peripheral blood stem cell transplant

Outcome Measures

Primary Outcomes (4)

  • blood count changes

    three months

  • T lymphocyte subsets

    three months

  • T cell functions

    3 months

  • adverse reactions

    24 hour

Secondary Outcomes (2)

  • relapse rate

    5 year

  • survival

    5 year

Study Arms (1)

CIK infusion

EXPERIMENTAL

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

Procedure: Infusion of autologous CIK cells

Interventions

Infusion of autologous CIK cellsPROCEDURE

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

CIK infusion

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (4)

  • 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. doi: 10.1046/j.1365-2141.2002.03247.x.

    PMID: 11841399BACKGROUND

  • 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. doi: 10.1016/j.bbmt.2004.11.019.

    PMID: 15744236BACKGROUND

  • 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. doi: 10.1038/sj.bjc.6690800.

    PMID: 10576658BACKGROUND

  • 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.

    PMID: 15840260BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Study Officials

  • Yeh-Ching Linn, MBBS, MRCP

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2006

First Posted

November 1, 2006

Study Start

October 1, 2006

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

SG(1)