Treatment with cytokine induced killer cells for leukaemia patients
| ISRCTN | ISRCTN25421117 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25421117 |
| Protocol serial number | 81070439 |
| Sponsor | Harbin Medical University First Affiliated Hospital (China) |
| Funders | National Natural Science Foundation of China ref: 81070439, 863 - Program in the "Eleventh Five" (China) ref: 2012AA020903, Science and Technology Platform, Heilongjiang (China) ref: PG09J003 |
- Submission date
- 05/09/2012
- Registration date
- 18/09/2012
- Last edited
- 23/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Department of Hematology
First Affiliated Hospital
Harbin Medical University
Harbin, Heilongjiang
150001
China
| Phone | +86 (0)451 53642767, 53641824 |
|---|---|
| zhoujin1111@126.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Consecutive autologous cytokine induced killer cell infusion for haematological malignancies and positron emission tomography (PET) scanning |
| Study objectives | 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(s) | Ethics and Health Research Committee of Hematology and Oncology, Heilongjiang, China, 08/06/2010, ref: 81070439 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Outcome of leukemia after CIK treatment at short-term follow up: 1 month, 3 months, 6 months and 1 year |
| Key secondary outcome measure(s) |
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 |
| Completion date | 15/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 298 |
| Total final enrolment | 9 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- China
Study participating centre
150001
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2014 | 23/10/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
07/02/2017: Plain English summary added.
08/12/2016: The overall trial end date has been updated from 31/12/2015 to 15/12/2017.
