Acute Myeloid LeukemiaPhase 1/2NCT00394381
Autologous Cytokine-induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome
A Phase 1/2 study testing Infusion of autologous CIK cells in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, High Grade, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, High Grade
- What is being tested?
- Infusion of autologous CIK cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2006to Jan 2012
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- uncontrolled infection
- life expectancy less than 6 weeks.
- Contraindication to undergo one session of leukapheresis for PBMNC harvesting
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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).
- Being tested
- Infusion of autologous CIK cells
- Keywords
- acute myeloid leukemia, myelodysplastic syndrome, autologous CIK cells, autologous peripheral blood stem cell transplant
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of autologous CIK cellsProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| CIK infusion | Experimental | Infusion of autologous CIK cells in study group. There is only one arm to this study Receives: Procedure: Infusion of autologous CIK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood count changes
Measured: three months
T lymphocyte subsets
Measured: three months
T cell functions
Measured: 3 months
adverse reactions
Measured: 24 hour
Secondary outcomes (2)
relapse rate
Measured: 5 year
survival
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
- Investigators
- Yeh-Ching Linn, MBBS, MRCP, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394381
- Sponsor's protocol ID
- CIK#1/2006
- Status last verified
- Feb 2017
- First submitted
- 31 Oct 2006
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1046/j.1365-2141.2002.03247.x.
PubMed 11841399Leemhuis 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.
PubMed 15744236Schmidt-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.
PubMed 10576658Jiang 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.
PubMed 15840260