UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008471 |
|---|---|
| Receipt number | R000009629 |
| Scientific Title | Post remission therapy including arsenic trioxide against acute promylocytic leukemia over 65 years old, Phase II Clinical Study (JALSG APL212G study) |
| Date of disclosure of the study information | 2012/07/19 |
| Last modified on | 2023/01/26 15:10:55 |
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Basic information
Public title
Post remission therapy including arsenic trioxide against acute promylocytic leukemia over 65 years old, Phase II Clinical Study (JALSG APL212G study)
Acronym
Post remission therapy including arsenic trioxide against acute promylocytic leukemia (APL) in elderly patients. (JALSG APL212G study)
Scientific Title
Post remission therapy including arsenic trioxide against acute promylocytic leukemia over 65 years old, Phase II Clinical Study (JALSG APL212G study)
Scientific Title:Acronym
Post remission therapy including arsenic trioxide against acute promylocytic leukemia (APL) in elderly patients. (JALSG APL212G study)
Region
| Japan |
Condition
Condition
Adult acute promylocytic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Investigate whether post remission therapy with arsenic trioxide (ATO) and tamibarotene (Am80), which are more specific and less toxic for acute promylocytic leukemia (APL), will improve the outcome or not in APL over 65 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
3-year event free survival (EFS)
Key secondary outcomes
1. Complete remission rate (CR)
2. 3- and 5-year disease free survival (DFS)of patients in CR
3. 3- and 5-year overall survival (OS)
4. 5-year event free survival (EFS)
5. CR, DFS and OS of each group
6. Adverse events.
7. Analyses of PML-RARA isoform, FLT3/ITD mutation, CD56 expression, additional chromosome abnormality and their effects on prognosis
8. Coagulation and fibrinolysis factors, and their effects on prognosis.
9. Quality of life
10. Determination of genetic abnormality and polymorphism of by genome and exome analyses for treatment related adverse events including APL differentiation syndrome.
11. Determination of genetic abnormality and polymorphism of by genome and exome analyses for the efficacy of treatment.
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
tamibarotene (Am80)
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
| 65 | 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. History of myelodysplastic syndrome
2. Atypical acute leukemia
3. Uncontrollable infection
4. Severe co-morbidity
5. Positive anti-HIV antibody, HBs antigen or anti-HCV antibody
6. Other active neoplasm
7. Pregnant and/or lactating woman
8. Psychological disorders
9. Patients who have a difficulty to enter the study.
Target sample size
63
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Takeshita |
Organization
Hamamatsu University School of Medicine
Division name
Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
TEL
(+81)-53-433-4993
akihirot@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Takeshita |
Organization
Hamamatsu University School of Medicine
Division name
Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
TEL
(+81)-53-433-4993
Homepage URL
http://www.jalsg.jp/
akihirot@hama-med.ac.jp
Sponsor or person
Institute
the Japan Adult Leukemia Study Group (JALSG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
the Nonprofit Supportive Organization for Cooperative Study on Adult Leukemia Treatment
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board of Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Hamamatsu, Higashi-ku, 431-3192, Japan
Tel
(+81)-53-435-2676
kenkyou@hama-med.ac.jp
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
| 2012 | Year | 07 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 19 | Day |
Last modified on
| 2023 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009629
