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Trial registered on ANZCTR


Registration number
ACTRN12611000988954
Ethics application status
Approved
Date submitted
14/09/2011
Date registered
16/09/2011
Date last updated
10/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigate the safety and efficacy of lymphoma immunotherapy
Scientific title
The safety and efficacy of tumour pulsed dendritic cells and cytokine induced killer cells for lymphoma and later stage pancreatic carcinoma treatment ex vivo
Secondary ID [1] 263043 0
Not applied yet
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lymphoma 270776 0
Pancreatic carcinoma. 285444 0
Condition category
Condition code
Cancer 270958 270958 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 285683 285683 0 0
Pancreatic
Cancer 285713 285713 0 0
Pancreatic
Cancer 285714 285714 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Alpha galactosyl epitopes are synthesized on lymphoma and pancreatic carcinoma cell membrane with alpha1,3-galactosyltransferase in vitro. Subsequently, the processed cancer cell membranes in the presence of human natural anti-Gal IgG, result in the opsonisation of the effective phagocytosis by dendritic cells which are co-cultured with the newly differentiated T/CIKs (cytokine induced killer cells) from bone marrow stem cells to generate tumour specific immune responders ex vivo. The lymphoma and pancreatic cancer patients receive the first injection on the third day of finishing the radio- or chemotherapy, and the subsequent doses are given every week. The first single dose is initiated at 2X10(9) cells iv injection. If no side-effects, iv injection dosage increases to 10X10(9) on the second week, and escalates to 20x10(9) cells on the third week. The total injections are 3-6 times depending on the avaibility of tumour sample. The safety and effectiveness are investigated. For example, the phenotype (CD3, CD4, CD8, CD16, CD19, CD45RO and CD56) and interferon-gamma expression in the peripheral blood lymphocytes are measured before injection and one week after the third injection.
Intervention code [1] 269387 0
Treatment: Other
Comparator / control treatment
before and after treatment compare
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279626 0
safety: for example allergy, auto-immune disease. Clinial lab test: ds-DNA, ANA(antinuclear antibody), AMA(antimitochondrial antibody), RF(rheumatoid factor), C3(complement-3 level) and LE cells (lupus erythematosus cell) etc.
Timepoint [1] 279626 0
the side-effects after three injecitons of DCs (dendritic cells)and CIKs(cytokine induced killer cells)
Secondary outcome [1] 294077 0
Effectiveness: 1. Survival time;
2. The measurement of tumour specific immune responders, e.g. The tumour-specific cytotoxicity will be measured by interferon-gamma ELISPOT( enzyme-linked immunospot assay) and the phenotype of the peripheral blood lymphocytes in the studied group will be analysed using flow cytometry before and one week after the third injection.
Timepoint [1] 294077 0
Measure the changes of tumour specific immuno-responders before and after three injections of DCs and CIKs

Eligibility
Key inclusion criteria
Karnofsky score> 70; low possible maintenance dose of glucocorticoid therapy (Prednisone 10mg/day, less than one month); no allergy to components of the DCs and CIKs.
Minimum age
12 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
cachexia; HIV positive; drug addictive, pregnant; severe pulmonary and cardiac diseases; history of an autoimmune disorder and prior history of other malignancies

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After a few courses of routine chemo- and radiotherapy, the relapsed lymphoma and later stage pancreatic carcinoma patients are enrolled in the study.Alpha-gal epitopes were synthesised on tumour cell membranes with alpha-1,3-galactosyltransferase in vitro. Subsequently, the addition of natural human anti-Gal IgG to the processed membranes resulted in the opsonisation and effective phagocytosis by DCs, which were co-cultured with newly differentiated T/CIKs from bone marrow stem cells to generate tumour-specific immune responders ex vivo.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Compare all the results before and after immunotherapy.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3844 0
China
State/province [1] 3844 0

Funding & Sponsors
Funding source category [1] 269851 0
Government body
Name [1] 269851 0
Key Clinical Program of Inner Mongolia Autonomous Region
Address [1] 269851 0
Ke Ji Da Sha, No.141, Xin Cheng Xi Jian, Huhhot, Inner Mongolia, PR China, 010010.
Country [1] 269851 0
China
Primary sponsor type
Hospital
Name
The First Teaching Hospital, Inner Mongolia Medical College
Address
The First Teaching Hospital, Tong Dao Beijian No.1, Huhhot, Inner Mongolia, 010050
Country
China
Secondary sponsor category [1] 268877 0
Hospital
Name [1] 268877 0
Aerospace Medical College, Peking University
Address [1] 268877 0
Aerospace Medical College, Peking University, No. 15 Yu Quan Road, Beijing, China 100049
Country [1] 268877 0
China
Secondary sponsor category [2] 268878 0
Hospital
Name [2] 268878 0
Armed Police General Hospital
Address [2] 268878 0
Armed Police General Hospital, No.69 Yongding Road
Haidian, Beijing, China, 100039
Country [2] 268878 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271826 0
The First Teaching Hospital, Inner Mongolia Medical College Ethics Committee
Ethics committee address [1] 271826 0
The First Teaching Hospital, Tong Dao Beijian No.1, Huhhot, Inner Mongolia
Ethics committee country [1] 271826 0
China
Date submitted for ethics approval [1] 271826 0
01/12/2009
Approval date [1] 271826 0
01/05/2010
Ethics approval number [1] 271826 0
20100501002

Summary
Brief summary
Dendritic cell (DC) and cytokine induced killer cell (CIK)-based therapy can induce specific antitumor T cell responses. This clinical pilot study examines feasibility and outcome of the tumour specific treatment for patients with advanced lymphoma and later stage pancreartic carcinoma. Procedures: Alpha-gal epitopes are synthesized on pancreatic carcinoma and lymphoma cell membrane with enzyme(alpha galactosyltransferase) in vitro. Subsequently, the processed membranes in the presence of human natural anti-Gal epitope IgG, resulted in the opsonisation of the effective phagocytosis by dendritic cells (DCs) which are co-cultured with cytokine induced killer cells (CIKs) to generate pancreatic carcinoma and lymphoma specific immune responders ex vivo.
Trial website
n/a
Trial related presentations / publications
4th Annual World Cancer Congress-2011
Public notes

Contacts
Principal investigator
Name 33158 0
Address 33158 0
Country 33158 0
Phone 33158 0
Fax 33158 0
Email 33158 0
Contact person for public queries
Name 16405 0
Sheng YUN
Address 16405 0
Department of Oncology, The First Teaching Hospital, Inner Mongolia Medical College, Huhhot, Inner Mongolia, 010050
Country 16405 0
China
Phone 16405 0
008615248158962
Fax 16405 0
0086(0)4716965931
Email 16405 0
sheng.yun@hotmail.co.uk
Contact person for scientific queries
Name 7333 0
Sheng YUN
Address 7333 0
Department of Oncology, The First Teaching Hospital, Inner Mongolia Medical College, Huhhot, Inner Mongolia, 010050
Country 7333 0
China
Phone 7333 0
008615248158962
Fax 7333 0
0086(0)4716965931
Email 7333 0
sheng.yun@hotmail.co.uk

No information has been provided regarding IPD availability
Summary results
No Results