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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005352
Receipt No. R000006342
Scientific Title A phase 2 study of dasatinib-combined chemotherapy in patients with relapsed Philadelphia chromosome-positive acute lymphoid leukemia.
Date of disclosure of the study information 2011/04/01
Last modified on 2012/01/03

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Basic information
Public title A phase 2 study of dasatinib-combined chemotherapy in patients with relapsed Philadelphia chromosome-positive acute lymphoid leukemia.
Acronym A phase 2 study of dasatinib-combined chemotherapy in patients with relapsed Philadelphia chromosome-positive acute lymphoid leukemia.
Scientific Title A phase 2 study of dasatinib-combined chemotherapy in patients with relapsed Philadelphia chromosome-positive acute lymphoid leukemia.
Scientific Title:Acronym A phase 2 study of dasatinib-combined chemotherapy in patients with relapsed Philadelphia chromosome-positive acute lymphoid leukemia.
Region
Japan

Condition
Condition Philadelphia chromosome positive acute lymphoblastic leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To find out the efficacy and safety of dasatinib-combined chemotherapy for patients with Philadelphia chromosome positive acute lymphoblastic leukemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Complete hematological remission rate in induction therapy
Key secondary outcomes Hematological remission rate
Complete cytogenetical remission rate
Major molecular remission rate
Overall survival rate at 1 year
Treatment related toxicity

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 Dasatinib combined chemotherapy
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
16 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria 1. Relapsed Ph-chromosome positive acute lymphoblastic leukemia.
2. PS 0-2 (ECOG)
3. Adequate hepatic, renal, pulmonary and cardiac function
4. No active gastro-intestinal bleeding
5. No evidence of CNS relapse
6. Written informed consent
Key exclusion criteria 1. Severe comorbidity
(infection, lung disease, hypertension, heart failure, diabetes mellitus)
2. Recent history of ischemic heart disease
3. Other active neoplasms
4. Pregnant and/or lactating woman

5. Psychological disorders

6. Positive HBs antigen and/or anti-HIV antibody
7. Received allogeneic stem cell transplantation within 100 days
8. Receiving immunosuppressive agents (cyclosporine, tacrolimus)
Target sample size 19

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Mizuta
Organization Fujita Health University
Division name Department of Hematology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake
TEL 0562-93-9243
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shuichi Mizuta
Organization Fujita Health University
Division name Department of Hematology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake
TEL 0562-93-9243
Homepage URL http://www.jalsg.jp/03/touroku.html
Email mizuta@mb.ccnw.ne.jp

Sponsor
Institute Japan Adult Leukemia Study Group
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) NPO JALSG supporting organization

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 JALSG参加の施設およびその関連病院とする。また更新される場合があるのでJALSGホームページに記載のある最新の施設を参照する。

北海道  (40都道府県)
青森県
宮城県
秋田県
山形県
福島県
栃木県
茨城県
群馬県
埼玉県
千葉県
東京都
神奈川県
新潟県
富山県
石川県
福井県
長野県
岐阜県
静岡県
愛知県
三重県
滋賀県
京都府
大阪府
兵庫県
奈良県
島根県
岡山県
広島県
山口県
香川県
愛媛県
高知県
福岡県
佐賀県
長崎県
熊本県
大分県
鹿児島県

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 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 Terminated
Date of protocol fixation
2011 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 06 Month 01 Day
Date trial data considered complete
2014 Year 07 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 30 Day
Last modified on
2012 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006342

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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