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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008471
Receipt No. 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 2018/02/20

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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
Middle name
Last name Akihiro Takeshita
Organization Hamamatsu University School of Medicine
Division name Internal Medicine
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
TEL (+81)-53-433-4993
Email akihirot@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Takeshita
Organization Hamamatsu University School of Medicine
Division name Internal Medicine
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
TEL (+81)-53-433-4993
Homepage URL http://www.jalsg.jp/
Email akihirot@hama-med.ac.jp

Sponsor
Institute the Japan Adult Leukemia Study Group (JALSG)
Institute
Department

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
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
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
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 19 Day
Last modified on
2018 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009629

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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