UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of Dasatinib monotherapy for Philadelphia positive acute lymphoblastic leukemia in the Elderly
Title of the study (Brief title)	DASPAL-E
Region	Japan

Condition
Condition	Philadelphia positive acutelymphoblastic leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safety of dasatinib monotherapy for elderly Ph+ALL or CML-LC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Event free survival rate at 1 year
Key secondary outcomes

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	dasatinib monotherapy
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	55 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Ph+ALL/CML-LC 2. age >=55 3. ECOG PS 0-3 4. No indication of HSCT 5. No dysfunction of liver and kidney 6. IC
Key exclusion criteria	1. active double cancer 2. uncontrollable complication 3. past history of TKI/chemotherapy 4. physicians' decision
Target sample size	25

Research contact person
Name of lead principal investigator	Naoto Takahashi
Organization	Akita Univ.
Division name	Dept. Hematology
Address	Hondo 1-1-1, Akita, Japan 010-5432
TEL	018-884-6115
Email	naotot@doc.med.akita-u.ac.jp

Public contact
Name of contact person	Naoto Takahashi
Organization	Study group of DASPAL-E
Division name	office
Address	1-1-1 Hondo, Akita city, Akita
TEL	+81-18-884-6115
Homepage URL
Email	theme_crc_takahashi@yahoo.co.jp

Sponsor
Institute	Study group of DASPAL-E
Institute
Department

Funding Source
Organization	NPO Tohoku Hematology Expert Meeting
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	秋田大学(秋田県）Akita Univ. (Akita)

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 12 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 03 Month 28 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 04 Month 12 Day
Last modified on	2018 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009113