UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007736 |
|---|---|
| Receipt number | R000009113 |
| Scientific Title | Phase II trial of Dasatinib monotherapy for Philadelphia positive acute lymphoblastic leukemia in the Elderly |
| Date of disclosure of the study information | 2012/04/12 |
| Last modified on | 2018/11/07 15:23:46 |
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Basic information
Public title
Phase II trial of Dasatinib monotherapy for Philadelphia positive acute lymphoblastic leukemia in the Elderly
Acronym
DASPAL-E
Scientific Title
Phase II trial of Dasatinib monotherapy for Philadelphia positive acute lymphoblastic leukemia in the Elderly
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Naoto Takahashi |
Organization
Akita Univ.
Division name
Dept. Hematology
Zip code
Address
Hondo 1-1-1, Akita, Japan 010-5432
TEL
018-884-6115
naotot@doc.med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Takahashi |
Organization
Study group of DASPAL-E
Division name
office
Zip code
Address
1-1-1 Hondo, Akita city, Akita
TEL
+81-18-884-6115
Homepage URL
theme_crc_takahashi@yahoo.co.jp
Sponsor or person
Institute
Study group of DASPAL-E
Institute
Department
Personal name
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)
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
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 |
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
| 2012 | Year | 03 | Month | 28 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009113
