Condition category
Cancer
Date applied
05/09/2012
Date assigned
18/09/2012
Last edited
19/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

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 below 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 measures

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.
The above tests need to be measured at diagnosis, short term and long term follow up after treatment.

Overall trial start date

01/01/2011

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants are 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

Other

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, Heilongjiang
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, NSFC

Funding Body Type

government organisation

Funding Body Subtype

Federal/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

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes