UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010642 |
|---|---|
| Receipt number | R000012447 |
| Scientific Title | Phase II study of multi-agent chemotherapy in patients with adult precursor T acute lymphoblastic leukemia. |
| Date of disclosure of the study information | 2013/05/15 |
| Last modified on | 2020/03/14 19:07:22 |
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Basic information
Public title
Phase II study of multi-agent chemotherapy in patients with adult precursor T acute lymphoblastic leukemia.
Acronym
Study of multi-agent chemotherapy in patients with adult precursor T acute lymphoblastic leukemia. (JALSG T-ALL213-O)
Scientific Title
Phase II study of multi-agent chemotherapy in patients with adult precursor T acute lymphoblastic leukemia.
Scientific Title:Acronym
Study of multi-agent chemotherapy in patients with adult precursor T acute lymphoblastic leukemia. (JALSG T-ALL213-O)
Region
| Japan |
Condition
Condition
precursor T acute lymphoblastic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate safety and efficacy of pediatric like protocols, which have a more intense use of agents such as L-asparaginase and steroids, as well as to clarify the relationship between prognosis and steroid reactivity in the treatment of newly diagnosed previously untreated adult precursor T acute lymphoblastic leukemia. Safety and efficacy of nelarabine will be also assessed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
3 year event free survival (EFS)
Key secondary outcomes
Complete remission rate
Adverse event rate
3 year overall survival (OS), and relapse free survival (RFS)
Efficacy and safety of hematopoietic stem cell transplantation such as treatment related mortality, relapse, engraftment, acute graft versus host disease (GVHD), and chronic GVHD
Relationship between initial steroid reactivity (Blast rates of bone marrow on Day 15) and prognosis such as OS, EFS and RFS
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
Induction therapy, Consolidation therapy, Maintenance therapy
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
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Recognized ALL
2. Precursor T-ALL (diagnosed by WHO Classification)
3. Age 25 to 64
4. Performance Status: 0 to 3
5. Adequate hepatic, renal and cardiac function
6. Written informed consent
Key exclusion criteria
1. Previously treated with leukapheresis
2. Congestive heart failure
3. Recent history of myocardial infarction
4. Malignant hypertension
5. Lung fibrosis
6. Interstitial pneumonitis
7. Severe comorbidity
(diabetes mellitus, infection or liver cirrhosis)
8. Positive anti-HIV antibody or HBs antigen
9. Thrombosis which need treatment
10. Psychological disorders
11. Other active neoplasms
12. Pregnant and/or lactating woman
13. Judged to be inadequate
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Hatta |
Organization
JALSG-ALL-213 research secretariat
Division name
Hematology and Rheumatology, Nihon University School ofMedicine
Zip code
173-8610
Address
30-1 Okaguchi Kami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
hatt.yosihiro@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Mori |
| Middle name | |
| Last name | Naoki |
Organization
JALSG-ALL-213 research secretariat
Division name
Tokyo Women Medical University, Department of Hematology
Zip code
162-0054
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
http://www.jalsg.jp
mori@dh.twmu.ac.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
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Hokuyu Hospital, IRB
Address
6-6-5-1 Higashi Sapporo, Shiroishi-ku, Sapporo
Tel
011-865-0111
iso.hokuyu@gmail.com
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参加施設
北海道 （39都道府県になります）
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
長崎県
熊本県
大分県
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 15 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 02 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 02 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 02 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 03 | Day |
Last modified on
| 2020 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012447
