Plain English Summary
Background and study aims
Cytokine-induced killer cells or CIK cells are a type of immune system cell that can be grown from a patient’s own cells in the lab and then given back to the patient to kill cancer cells. CIK treatment could be used to treat patients with leukemia (cancer of the white blood cells). The aim of this study is to find out whether CIK treatment improves the disease outcome of leukemia patients and reduces the number of chemotherapy cycles required.
Who can participate?
Patients aged between 5 and 60 with leukemia
What does the study involve?
Participants are treated with either standard chemotherapy or chemotherapy combined with CIK treatment. Their clinical outcome is closely monitored with prompt supportive treatment and relapse prevention treatment. Whole body PET/CT scans are used to monitor disease development. At the end of the study, the relapse-free period and overall survival rates are compared among different age groups, leukemia types and treatment strategies.
What are the possible benefits and risks of participating?
This study should help to improve the well-being of leukemia patients in China. Immediate direct benefits are expected to be observed with CIK treatment. The side effects of chemotherapy would be reduced with the use of CIK treatment. The long-term tumor-killing effects of CIK cells remain unknown and are likely to be vary by person. The main risk of giving CIK cells to leukemia patients is infection from contamination of cultured blood products. Therefore, good manufacturing practice conditions are strictly followed. Participants are closely monitored during treatment.
Where is the study run from?
First Affiliated Hospital of Harbin Medical University (China)
When is the study starting and how long is it expected to run for?
January 2011 to December 2017
Who is funding the study?
1. National Natural Science Foundation (China)
2. 863-Program in the "Eleventh Five" (China)
3. Science and Technology Platform in Heilongjiang (China)
Who is the main contact?
Prof. Jin Zhou
zhoujin1111@126.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jin Zhou
ORCID ID
Contact details
Department of Hematology
First Affiliated Hospital
Harbin Medical University
Harbin
Heilongjiang
150001
China
+86 (0)451 53642767, 53641824
zhoujin1111@126.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
81070439
Study information
Scientific title
Consecutive autologous cytokine induced killer cell infusion for haematological malignancies and positron emission tomography (PET) scanning
Acronym
Study hypothesis
A consecutive autologous cytokine induced killer (CIK) cell infusion combined with chemotherapy, applied to hematological malignancy patients reduces the incidence of chemotherapy complications, improves prognosis with PET/computerised tomography (CT) scan evaluation.
Ethics approval
Ethics and Health Research Committee of Hematology and Oncology, Heilongjiang, China, 08/06/2010, ref: 81070439
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Hematological malignancies
Intervention
Participants are volunteered to be divided into two groups.
1. Standard chemotherapy
2. Chemotherapy combined with autologous CIK infusion
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
1. Outcome of leukemia after CIK treatment at short-term follow up: 1 month, 3 months, 6 months and 1 year
2. Remission or relapse evaluation at long-term follow up: 1 year, 2 years, 3 years, 4 years and 5 years (end of study)
Secondary outcome measures
1. Age, white blood cell (WBC) count, platelet count, hemoglobin (Hb) level, percentage of leukemia cells in bone marrow and absolute number in peripheral blood. Karyotypic findings with cytogenetic markers
2. Type of treatment, number of treatment cycles to achieve remission
3. Minimal residual disease evaluation with whole body PET/CT scan, in-vivo CIK cell function sites with FDG labeling PET/CT scan
Measured at diagnosis, short-term and long-term follow up after treatment
Overall trial start date
01/01/2011
Overall trial end date
15/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Community-dwelling leukemia patients
2. 5 to 60 years old, who would volunteer to accept autologous CIK cell treatment
3. Volunteer to accept chemotherapy but reject autologous CIK cell treatment
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
n=298
Participant exclusion criteria
1. Previous history of severe cardiovascular disease (coronary arterial disease, stroke, etc)
2. Severe chronic disease with poor prognosis (liver disease, kidney disease, etc)
3. Illegal drug use or chronic alcoholism
4. Physical limitations, mental or intellectual disabilities
5. Any condition that may affect the development of this trial
Recruitment start date
01/01/2011
Recruitment end date
31/12/2015
Locations
Countries of recruitment
China
Trial participating centre
Harbin Medical University First Affiliated Hospital
Harbin
150001
China
Sponsor information
Organisation
Harbin Medical University First Affiliated Hospital (China)
Sponsor details
Youzheng Street
Nangang District
Harbin
Heilongjiang
150001
China
+86 (0)451 53642767, 53641824
zhoujin1111@126.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
National Natural Science Foundation of China ref: 81070439
Alternative name(s)
National Science Foundation of China, Natural Science Foundation of China, Chinese National Science Foundation, NSFC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
China
Funder name
863 - Program in the "Eleventh Five" (China) ref: 2012AA020903
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Science and Technology Platform, Heilongjiang (China) ref: PG09J003
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list