UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000796 |
|---|---|
| Receipt number | R000000955 |
| Scientific Title | Cellular immunotherapy for acute myeloid leukemia using dendritic cells pulsed with WT1 peptide and zoledronate |
| Date of disclosure of the study information | 2007/08/10 |
| Last modified on | 2009/12/25 18:31:02 |
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Basic information
Public title
Cellular immunotherapy for acute myeloid leukemia using dendritic cells pulsed with WT1 peptide and zoledronate
Acronym
Cellular immunotherapy for acute myeloid leukemia using dendritic cells pulsed with WT1 peptide and zoledronate
Scientific Title
Cellular immunotherapy for acute myeloid leukemia using dendritic cells pulsed with WT1 peptide and zoledronate
Scientific Title:Acronym
Cellular immunotherapy for acute myeloid leukemia using dendritic cells pulsed with WT1 peptide and zoledronate
Region
| Japan |
Condition
Condition
acute myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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. Immune responses to WT1 and KLH
2. Responses of gamma delta T cells
3. Complete remission rate
4. Partial remission rate evaluated by microscopy
5. Partial remission rate evaluated by flow cytometry or WT1 mRNA real-time RT-PCR
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 and intravenously 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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed as acute myeloid leukemia
2. HLA-A*2402 positive
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
6
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
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/
kadowaki@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Hematology and Oncology, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Medinet Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2007 | Year | 08 | Month | 10 | 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 | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 08 | Month | 09 | Day |
Last modified on
| 2009 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000955
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