UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003434 |
|---|---|
| Receipt number | R000004158 |
| Scientific Title | The phase IV study for comparing the response of high-dose cytarabine therapy among the KIT mutation status in adult core binding factor acute myeloid leukemia. -JALSG CBF-AML209-KIT Study (CBF-AML209-KIT)- |
| Date of disclosure of the study information | 2010/04/02 |
| Last modified on | 2020/04/09 10:38:51 |
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Basic information
Public title
The phase IV study for comparing the response of high-dose cytarabine therapy among the KIT mutation status in adult core binding factor acute myeloid leukemia.
-JALSG CBF-AML209-KIT Study (CBF-AML209-KIT)-
Acronym
The study for comparing the response of high-dose cytarabine therapy among the KIT mutation status in adult core binding factor acute myeloid leukemia.
Scientific Title
The phase IV study for comparing the response of high-dose cytarabine therapy among the KIT mutation status in adult core binding factor acute myeloid leukemia.
-JALSG CBF-AML209-KIT Study (CBF-AML209-KIT)-
Scientific Title:Acronym
The study for comparing the response of high-dose cytarabine therapy among the KIT mutation status in adult core binding factor acute myeloid leukemia.
Region
| Japan |
Condition
Condition
Acute myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the adequate application of the high-dose cytarabine post-remission therapy according to the KIT mutation status to adult core binding factor-acute myeloid leukemia with t(8;21)(q22;q22), inv(16)(p13.1q22)/t(16;16)(p13.1;q22).
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Disease-free survival at 2 years in CBF-AML patients with or without KIT mutation.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Consolidation therapy consisted of 3 courses of high-dose cytarabine.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) JALSG AML209-GS study registered patient.
(2) The patients with RUNX1-RUNX1T1 and CBFB-MYH11 transcripts.
(3) The patients who achieved CR within 2 courses of the induction therapy
(4) The patients who are not received the post-remission therapy.
(5) The patients with Performance status grade (ECOG) 0,1 or 2.
(6) The patients with the chemotherapy tolerable liver, kidney, lung and cardiac functions.
Key exclusion criteria
(1) Secondary AML
(2) The patients with the past history of hematopoietic disorder.
(3) The patients who received the craniotomy.
(4) The patients who received the total skull irradiation.
(5) The patients who received the radiation therapy.
(6) The patients who have been identified the cancer after the registration to the JALSG AML209-GS study.
(7) The patients who have developed myocardial infarction or angina after the registration to the JALSG AML209-GS study.
(8) The patients with cardiac dysfunction.
(9) The patients with active gastric ulcer.
(10) The patients with the uncontrollable ileus.
(11) The patients with the diabetes mellitus.
(12) The patients with active infection.
(13) The patients in whom the HBV-reactivation have been observed.
(14) Psycological patients.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kiyoi |
Organization
Nagoya University Hospital
Division name
Department of IHematology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2136
kiyoi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kiyoi |
Organization
Nagoya University Hospital
Division name
Department of Hematology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2136
Homepage URL
kiyoi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Japan adult leukemia study group
Institute
Department
Personal name
Funding Source
Organization
NPO JALSG supporting organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Ethical committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
052-744-2804
ethics@med.nagoya-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 02 | 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
Main results already published
Date of protocol fixation
| 2010 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2010 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 02 | Day |
Last modified on
| 2020 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004158
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