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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010619
Receipt No. R000012415
Scientific Title Phase II study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia.
Date of disclosure of the study information 2013/05/15
Last modified on 2020/05/07

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Basic information
Public title Phase II study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia.
Acronym Study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia. (JALSG Ph(-)B-ALL213)
Scientific Title Phase II study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia.
Scientific Title:Acronym Study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia. (JALSG Ph(-)B-ALL213)
Region
Japan

Condition
Condition Philadelphia chromosome negative precursor B 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 Philadelphia chromosome negative precursor B acute lymphoblastic leukemia.
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
15 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Recognized ALL
2. Precursor B-ALL (diagnosed by WHO Classification)
3. Age 15 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 160

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Hatta
Organization JALSG-ALL213 research secretariat
Division name Hematology and Rheumatology, Nixon University School of Medicine
Zip code 173-8610
Address 30-1 Okaguchi Kami-cho, Itabashi-ku, Tokyo
TEL 03-3972-8111
Email hatta.yoshihiro@nihon-u.ac.jp

Public contact
Name of contact person
1st name Yoshihiro
Middle name
Last name Hatta
Organization JALSG-ALL213 research secretariat
Division name Hematology and Rheumatology, Nixon University School of Medicine
Zip code 173-8610
Address 30-1 Okaguchi Kami-cho, Itabashi-ku, Tokyo
TEL 03-3972-8111
Homepage URL http://www.jalsg.jp
Email hatta.yoshihiro@nihon-u.ac.jp

Sponsor
Institute Japan Adult Leukemia Study Group
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Deveopment
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, Sappro
Tel 011-865-0111
Email 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

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 211
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
2013 Year 04 Month 22 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 04 Month 30 Day
Last modified on
2020 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012415

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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