UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015348 |
|---|---|
| Receipt number | R000017854 |
| Scientific Title | A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL) |
| Date of disclosure of the study information | 2014/10/06 |
| Last modified on | 2022/04/11 14:59:23 |
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Basic information
Public title
A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)
Acronym
JPLSG AML-P13
Scientific Title
A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)
Scientific Title:Acronym
JPLSG AML-P13
Region
| Japan |
Condition
Condition
Acute promyelocytic leukemia
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate an efficacy and safety of the treatment strategy consisted of 2 courses of multi-agent chemotherapy followed by 3 courses of consolidation therapy with either ATO and/or GO.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Three-year event-free survival rate
Key secondary outcomes
Remission induction rate
Molecular remission rate at the end of consolidation therapy
Three-year overall survival rate
Rate of DIC, APL-DS, and mortality during first remission induction therapy
Rate of adverse events during ATO therapy
Rate of adverse events
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 eligible patients receive 2 courses of induction therapy comprising ATRA, cytarabine and anthracyclines.
Patients who achieved hematological CR (standard risk group) receive 3 courses of consolidation therapy comprising ATRA and ATO, followed by 1 year of maintenance therapy consist of intermittent ATRA.
Patients who did not achieve hematological CR (high risk group) receive 3 courses of consolidation therapy comprising either ATO or GO, followed by 1 year of maintenance therapy consist of 6MP and MTX.
Patients with molecular persistence at the end of consolidation therapy (molecular persistence group) receive single-agent reinduction therapy of GO.
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
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient with a diagnosis of APL genetically or cytogenetically diagnosed by either one of three methods; karyotyping, FISH, or RT-PCR.
ECOG performance status score of 0-2, or of 3 when caused by leukemia.
No previous treatment.
Written informed consent obtained either from patient or guardians.
Key exclusion criteria
17q12/RARA not detected genetically and cytogenetically
APL with t(11;17)(q23;q12)/PLZF-RARA
CNS hemorrhage which is likely to interfere protocol therapy
Secondary APL due to previous chemotherapy or radiation therapy
Unmanageable infectious disease including tuberculosis
Any inappropriate status judged by physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Toho University
Division name
Department of Pediatrics
Zip code
143-8451
Address
6-11-1 Omorinishi, Ota-ku, Tokyo 143-8451
TEL
03(3762)4151
taccn@fb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Toho University
Division name
Department of Pediatrics
Zip code
143-8451
Address
6-11-1 Omorinishi, Ota-ku, Tokyo 143-8451
TEL
03(3762)4151
Homepage URL
http://jplsg.jp/
taccn@fb3.so-net.ne.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department
Personal name
Funding Source
Organization
Grant for clinical cancer research from the Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Grant from the National Center for Child Health and Development
IRB Contact (For public release)
Organization
Ethics Committee, Toho University Omori Medical Center
Address
6-11-1 Omorinishi, Ota-ku, Tokyo 143-8451
Tel
03(3762)4151
omori.rinri@ext.toho-u.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
| 2014 | Year | 10 | Month | 06 | 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
32
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
| 2014 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 06 | Day |
Last modified on
| 2022 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017854
