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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001024
Receipt No. R000001235
Scientific Title Cellular immunotherapy for acute myeloid leukemia using dendritic cells that endocytosed autologous leukemic cells
Date of disclosure of the study information 2008/02/12
Last modified on 2009/08/12

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Basic information
Public title Cellular immunotherapy for acute myeloid leukemia using dendritic cells that endocytosed autologous leukemic cells
Acronym Cellular immunotherapy for acute myeloid leukemia using dendritic cells that endocytosed autologous leukemic cells
Scientific Title Cellular immunotherapy for acute myeloid leukemia using dendritic cells that endocytosed autologous leukemic cells
Scientific Title:Acronym Cellular immunotherapy for acute myeloid leukemia using dendritic cells that endocytosed autologous leukemic cells
Region
Japan

Condition
Condition acute myeloid leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of dendritic cell immunotherapy for residual acute myeloid leukemia after chemotherapy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Toxicity of NCI-CTC grade 1-4
Key secondary outcomes 1. Immunological monitoring
2. Complete remission rate
3. Partial remission rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 Administer monocyte-derived dendritic cells intradermally every 2 weeks for 5 doses
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria 1. Diagnosed as acute myeloid leukemia
2. More than 5 x 107 autologous leukemic cells have been stocked
3. Expression of WT1 in leukemic cells is confirmed by the following criteria
1) WT1 mRNA, more than 1,000 copy/microgram RNA for bone marrow
2) WT1 mRNA, more than 10 copy/microgram RNA for peripheral blood
4. Leukemic cells are detected after chemotherapy, based on the following criteria
1) 5% or more and less than 20% blasts on bone marrow smear
2) 0.1% or more and less than 20% leukemic cells on flow cytometry
3) WT1 mRNA, more than 1,000 copy/microgram RNA for bone marrow or more than 10 copy/microgram RNA for peripheral blood by real-time RT-PCR
4) pathologically diagnosed extramedullary lesions detected by physical examination of CT scan
5. Performance status (ECOG) 0-2
6. No chemotherapy has been performed within 4 weeks before informed consent
7. Meet the following criteria for organ functions
1) Serum creatinine less than 3 folds of the upper normal limit
2) Serum bilirubin less than 2.0 mg/dL
3) Serum AST/GOT less than 5 folds of the upper normal limit
4) Ejection fraction of cardiac left ventricle more than 40% by ultrasonography
5) Arterial oxygen saturation more than 93% in room air
8. Ineligible for hematopoietic stem cell transplantation, or the patient does not wish to receive it
9. Informed consent has been obtained
Key exclusion criteria 1. There is deep seated active infection
2. There are other malignancies
3. There are leukemic lesions in the central nervous system
4. There is active autoimmune disease
5. Positive for HBs Ag, HCV Ab, HTLV-I Ab, HIV Ab, or serological test for syphilis
6. Responsible doctors judged the patient inappropriate for the trial
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Ishikawa
Organization Kyoto University Hospital
Division name Department of Hematology and Oncology
Zip code
Address 54 Shogoin Kawara-cho, Sakyo-ku
TEL 075-751-3155
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norimitsu Kadowaki
Organization Kyoto University Hospital
Division name Department of Hematology and Oncology
Zip code
Address 54 Shogoin Kawara-cho, Sakyo-ku
TEL 075-751-4964
Homepage URL http://www.kuhp.kyoto-u.ac.jp/
Email kadowaki@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Hematology and Oncology, Kyoto University Hospital
Institute
Department

Funding Source
Organization Kyoto University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 02 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
2009 Year 06 Month 01 Day
Date trial data considered complete
2009 Year 06 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 02 Month 12 Day
Last modified on
2009 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001235

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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