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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000302
Receipt No. 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

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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
Email

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
Email nemi@fujita-hu.ac.jp

Sponsor
Institute Japan adult leukemia study group ( JALSG)
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000329

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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