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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016494
Receipt No. 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

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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
Email 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
Email osumi-t@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018571

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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