UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016494 |
|---|---|
| Receipt number | R000018571 |
| Scientific Title | A Pilot Study of Dasatinib for Relapsed or Refractory ABL1/PDGFRB Rearrangemennt Positive Ph-like Acute Lymphoblasic Leukemia |
| Date of disclosure of the study information | 2015/02/10 |
| Last modified on | 2016/07/25 08:22:46 |
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Basic information
Public title
A Pilot Study of Dasatinib for Relapsed or Refractory ABL1/PDGFRB Rearrangemennt Positive Ph-like Acute Lymphoblasic Leukemia
Acronym
D-APPLE STUDY
Scientific Title
A Pilot Study of Dasatinib for Relapsed or Refractory ABL1/PDGFRB Rearrangemennt Positive Ph-like Acute Lymphoblasic Leukemia
Scientific Title:Acronym
D-APPLE STUDY
Region
| Japan |
Condition
Condition
ABL1/PDGFRB Rearrangemennt Positive Ph-like Acute Lymphoblasic Leukemia
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To collect basic data of Dasatinib for the cases with primary refractory or recurrent ABL1/PDGFRB rearrangement positive Ph-like ALL focusing on its efficacy and safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Toxic effects of dasatinib at the dose of 60 mg per square meter body surface area
Key secondary outcomes
- decay rate of blasts in peripheral blood
- decay rate of blasts in bone-marrow blood
- achievement rate of complete remission
- PK study of dasatinib
- TKI sensitivity test in vitro
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Taking orally of Dasatinib 60mg per square meter body surface area once a day for two weeks
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
| 1 | years-old | <= |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) primary refractory or relapsed ALL
2) ABL1 or PDGFRB Rearrangemennt is confirmed by FISH or PCR method
3) relapsed cases: over 25% blasts in bone-marrow at the time of study enrollment
refractory cases: over 5% blasts in bone-marrow at the time of study enrollment
4) without history of previous chemotherapy after diagnosis of primary refractory or relapse (other than steroids within 10 days or intrathecal infusion)
5) Age 1 year to 20 years old at the time of study enrollment
6) ECOG performance status (PS) score of 0-2
7) Patients must have sufficient organ function
8) All patients and/or their parents or legal guardians must sign a written informed consent
Key exclusion criteria
1) Patients with severe CNS or gastrointestinal hemorrhage (grade 2 or higher in CTCAE ver4.0)
2) Patients with severe fluid retention (grade 2 or higher in CTCAE ver4.0)
3) QTc is more than 0.45 seconds
4) Patients with uncontrollable infection (including those with active tuberculosis or positive HIV antibody)
5) Patient with a history of organ transplantation other than stem cell transplantation
6) Patient with uncontrollable diabetes mellitus
7) Patients with history of primary or acquired immunodeficiency
8) Patients who are pregnant
9) Patient with 21-trisomy
10) Patient with severe mental retardation
11) Patients with any other inappropriate status judged by physician
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoo Osumi |
Organization
National Center for Child Health and Development
Division name
Division of Leukemia and lymphoma, Children's Cancer Center
Zip code
Address
2-10-1 Okura Setagaya-ku Tokyo,157-8535 Japan
TEL
03-3416-0181
osumi-t@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoo Osumi |
Organization
National Center for Child Health and Development
Division name
Division of Leukemia and lymphoma, Children's Cancer Center
Zip code
Address
2-10-1 Okura Setagaya-ku Tokyo,157-8535 Japan
TEL
03-3416-0181
Homepage URL
osumi-t@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
- Japan Leukemia Research Fund
- Children's Cancer Association of Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
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
国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 10 | 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
| 2015 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 09 | 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
| 2015 | Year | 02 | Month | 09 | Day |
Last modified on
| 2016 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018571
