UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000302 |
|---|---|
| Receipt number | R000000329 |
| Scientific Title | Phase II Clinical Trial to test efficacy and safety of relapsed APL (JALSG APL205R study) |
| Date of disclosure of the study information | 2005/12/30 |
| Last modified on | 2013/06/30 14:17:55 |
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Basic information
Public title
Phase II Clinical Trial to test efficacy and safety of relapsed APL (JALSG APL205R study)
Acronym
Phase II Clinical Trial for relapsed APL (JALSG APL205R study)
Scientific Title
Phase II Clinical Trial to test efficacy and safety of relapsed APL (JALSG APL205R study)
Scientific Title:Acronym
Phase II Clinical Trial for relapsed APL (JALSG APL205R study)
Region
| Japan |
Condition
Condition
relapsed acute promyelocytic leukemia (APL)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the efficiency and safety of a series of treatment from arsenic trioxide(ATO) therapy to autologous transplantation for relapsed APL patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Disease free survival at 1 year
Key secondary outcomes
1.Frequency of abnormal reactions
2.Complete remission rate
3.The amount of CD34 positive cell in PBSCH
4.Frequency of PML/RAR positivity
5.Engraftment of autologous stem cell transplantation
6.Overall Survival
7.Risk analysis
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
This protocol is composed of the following four steps of therapy.
1.Induction therapy :Arsenic trioxide regime
2.Consolidation therapy: two couses of ATO regime
3.PBSCH: High dose araC regime
4.Autologous PBSCT
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Relapsed APL
2. Age between 18 and 65 years
3. Performance status between 0 and 3 (ECOG criteria)
4. Adequate functioning of the liver (serum bilirubin level < 2.0 mg/dL), kidneys (serum creatinine level < 2.0 mg/dL), lung (PaO2 > 60 mmHg or SpO2 > 93%) and heart (no severe abnormalities detected on electrocardiograms)
5. Written informed consent to participate the trial
Key exclusion criteria
1. Uncontrolled active infection
2. Past history of myocardial infarction or cardiac failure
3. Past history of renal failure
4. Uncontrolled diabetes mellitus
5. Liver cirrhosis
6. Abnormal reaction to ATO and AraC
7. Another severe and/or life threatening disease
8. Pregnant and/or lactating woman
9. Relapse after stem cell transplantation
10.Impossible to process this protocol
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiko EMI |
Organization
Japan adult leukemia study group ( JALSG APL205R)
Division name
Dep. of Hematology
Zip code
Address
Fujita Health University School of Medicine
TEL
0562-93-9243
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhiko EMI |
Organization
JALSG
Division name
Office for JALSG APL205R
Zip code
Address
Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, JAPAN
TEL
0562-93-9243
Homepage URL
nemi@fujita-hu.ac.jp
Sponsor or person
Institute
Japan adult leukemia study group ( JALSG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Helath,Labor and Walfare
Organization
Division
Category of Funding 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
JALSG参加施設
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 12 | Month | 30 | Day |
Related information
URL releasing protocol
http://www2.hama-med.ac.jp/w4a/jalsg/seikapage3.htm
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/23412094
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
| 2005 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 12 | Month | 29 | Day |
Last modified on
| 2013 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000329
