Treatment with cytokine induced killer cells for leukaemia patients

ISRCTN ISRCTN25421117
DOI https://doi.org/10.1186/ISRCTN25421117
Secondary identifying numbers 81070439
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Jin Zhou
Scientific

Department of Hematology
First Affiliated Hospital
Harbin Medical University
Harbin, Heilongjiang
150001
China

Phone +86 (0)451 53642767, 53641824
Email zhoujin1111@126.com

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleConsecutive autologous cytokine induced killer cell infusion for haematological malignancies and positron emission tomography (PET) scanning
Study objectivesA 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) studiedHematological malignancies
InterventionParticipants are volunteered to be divided into two groups.
1. Standard chemotherapy
2. Chemotherapy combined with autologous CIK infusion
Intervention typeMixed
Primary outcome measure1. 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 measures1. 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 study start date01/01/2011
Completion date15/12/2017

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participantsn=298
Total final enrolment9
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2011
Date of final enrolment31/12/2015

Locations

Countries of recruitment

  • China

Study participating centre

Harbin Medical University First Affiliated Hospital
Harbin
150001
China

Sponsor information

Harbin Medical University First Affiliated Hospital (China)
Hospital/treatment centre

Youzheng Street
Nangang District
Harbin
Heilongjiang
150001
China

Phone +86 (0)451 53642767, 53641824
Email zhoujin1111@126.com
ROR logo "ROR" https://ror.org/05vy2sc54

Funders

Funder type

Research organisation

National Natural Science Foundation of China ref: 81070439
Government organisation / National government
Alternative name(s)
Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
Location
China
863 - Program in the "Eleventh Five" (China) ref: 2012AA020903

No information available

Science and Technology Platform, Heilongjiang (China) ref: PG09J003

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planNot provided at time of registration
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

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.