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

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 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


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

Value
https://center6.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