UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005352 |
|---|---|
| Receipt number | 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 00:33:48 |
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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
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
mizuta@mb.ccnw.ne.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006342
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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