UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012004 |
|---|---|
| Receipt number | R000013271 |
| Scientific Title | Phase 2 study of ATRA and arsenic trioxide for acute promyelocytic leukemia |
| Date of disclosure of the study information | 2013/10/09 |
| Last modified on | 2018/04/18 12:35:27 |
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Basic information
Public title
Phase 2 study of ATRA and arsenic trioxide for acute promyelocytic leukemia
Acronym
Phase 2 study of ATRA and arsenic trioxide for acute promyelocytic leukemia
Scientific Title
Phase 2 study of ATRA and arsenic trioxide for acute promyelocytic leukemia
Scientific Title:Acronym
Phase 2 study of ATRA and arsenic trioxide for acute promyelocytic leukemia
Region
| Japan |
Condition
Condition
acute promyelocytic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of all-trans retinoic acid (ATRA) and arsenic trioxide for acute promylocytic leukemia (APL)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Complete remission rate (CR)
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
| Medicine |
Interventions/Control_1
all-trans retinoic acid
idarubicin
arsenic trioxide
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
1. Newly diagnosed APL (FAB: M3 or M3v)
2. Performance status (ECOG): 0-2
3. Adequate cardiac, pulmonary, hepatic and renal function
4. Written informed consent
Key exclusion criteria
1. Severe co-morbidity
2. Pregnant and/or lactating woman
3. Patients who have a difficulty to enter the study.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Ichinohe |
Organization
Hiroshima University Hospital
Division name
Department of Hematology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, JAPAN
TEL
082-257-5861
nohe@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Imagawa |
Organization
Hiroshima University Hospital
Division name
Department of Hematology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, JAPAN
TEL
082-257-5861
Homepage URL
imagawa@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Hematology, Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 09 | Day |
Last modified on
| 2018 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013271
