Treatment with cytokine induced killer cells for leukaemia patients

Not Applicable

Completed

• Conditions: Hematological malignancies; Cancer; Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue

• Registration Number: ISRCTN25421117
• Lead Sponsor: Harbin Medical University First Affiliated Hospital (China)

Brief Summary

2014 results in https://pubmed.ncbi.nlm.nih.gov/24929848/ (added 23/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-18
• Study Completion: 2017-12-15
• Last Update Posted: 2 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 9

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Outcome of leukemia after CIK treatment at short-term follow up: 1 month, 3 months, 6 months and 1 year<br> 2. Remission or relapse evaluation at long-term follow up: ?1 year, 2 years, 3 years, 4 years and 5 years (end of study)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Type of treatment, number of treatment cycles to achieve remission<br> 3. Minimal residual disease evaluation with whole body PET/CT scan, in-vivo CIK cell function sites with FDG labeling PET/CT scan<br> Measured at diagnosis, short-term and long-term follow up after treatment<br>