UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015870 |
|---|---|
| Receipt number | R000018470 |
| Scientific Title | Phase 2 trial for hematological CR patients of AML after chemotherapy. |
| Date of disclosure of the study information | 2014/12/08 |
| Last modified on | 2020/01/20 16:30:28 |
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Basic information
Public title
Phase 2 trial for hematological CR patients of AML after chemotherapy.
Acronym
Phase 2 trial for hematological CR patients of AML after chemotherapy.
Scientific Title
Phase 2 trial for hematological CR patients of AML after chemotherapy.
Scientific Title:Acronym
Phase 2 trial for hematological CR patients of AML after chemotherapy.
Region
| Japan |
Condition
Condition
Acute myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Make sure the effectiveness of WT1-peptide therapy for protection against relapse for the hematological CR petients after chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 year OS, 2 year OS
1 year DFS, 2 year DFS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
WT1 peptide vaccine therapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
AML patients who archive the hematological CR after chemotherapy.
The main organ fucntion is OK.
(AST<normal limit*4, ALT<normal limit*4, T-bil<2.0mg/dl, Cr<2.0mg/dl,ECG is OK, SpO2>94%)
HLA-A is A0201 or A2402.
Hematopoietic function recovers over below.
(Neu>1000, Plt>50.000, Hb 7.0)
Key exclusion criteria
AML associated with MPD
double cancer
active infection
post hematological stem cell transplantation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruo Sugiyama |
Organization
Osaka University
Division name
Functional Diagnostic Science
Zip code
Address
2-15 Yamadaoka in Suita city
TEL
06-6879-3676
clinical-trial@cit.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Nakata |
Organization
Osaka University
Division name
Cancer Immunotherapy
Zip code
Address
2-15 Yamadaoka in Suita city
TEL
06-6879-3676
Homepage URL
clinical-trial@cit.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Cancer Immunotyerapy of Osaka University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2014 | Year | 12 | Month | 08 | 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
| 2011 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2011 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 08 | Day |
Last modified on
| 2020 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018470
