UMIN-CTR Clinical Trial

Basic information
Public title	Clinical observation study of 5-year survivals in patients with newly diagnosed acute lymphoblastic leukemia (ALL) in Japan Adult Leukemia Study Group (JALSG). (JALSG-ALL-CS-12)
Acronym	JALSG ALL clinical observation study 12 (JALSG-ALL-CS-12)
Scientific Title	Clinical observation study of 5-year survivals in patients with newly diagnosed acute lymphoblastic leukemia (ALL) in Japan Adult Leukemia Study Group (JALSG). (JALSG-ALL-CS-12)
Scientific Title:Acronym	JALSG ALL clinical observation study 12 (JALSG-ALL-CS-12)
Region	Japan

Condition
Condition	Acute lymphoblastic leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	5-year survivals of acute lymphoblastic leukemia (ALL) and efficacy of stem cell transplantation therapy in the treatment of ALL, and accumulation of data for conducting JALSG ALL protocol.
Basic objectives2	Others
Basic objectives -Others	clinical observation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) ALL patient 5-year survivals (2) Effect of stem cell transplantation (SCT) on ALL patients (3) Effect of timing of SCT and conditioning regimen on ALL patients (4) Numbers of patients with ALL by age group, sex and type of diseases (5) Feasibility of classification according to known prognostic factors (6) Description of patients' status in chemotherapy program (7) Remission duration due to chemotherapy
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Previously untreated ALL
Key exclusion criteria	Past history of chemotherapy or stem cell transplantation in the treatment of ALL
Target sample size	733

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Hatta
Organization	JALSG-ALL-CS-12 research secretariat
Division name	Hematology and Rheumatology, Nihon University School of Medicine
Zip code	173-8610
Address	30-1 Okaguchi Kami-cho, Itabashi-ku, Tokyo
TEL	03-3972-8111
Email	hatta.yosihiro@nihon-u.ac.jp

Public contact
Name of contact person	1st name Yoshihiro Middle name Last name Hatta
Organization	JALSG-ALL-CS-12 research secretariat
Division name	Hematology and Rheumatology, Nihon 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.yosihiro@nihon-u.ac.jp

Sponsor
Institute	Japan Agency for Medical Research and Development Japan Adult Leukemia Study Group
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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 hsopital IRB
Address	6-6-5-1 Higashi-Spporo, Shiroishi-ku, Sapporo
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	2012 Year 04 Month 03 Day

Related information
URL releasing protocol	http://www.jalsg.jp
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	2012 Year 02 Month 06 Day
Date of IRB	2015 Year 03 Month 30 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 01 Day
Date of closure to data entry	2021 Year 07 Month 01 Day
Date trial data considered complete	2021 Year 12 Month 01 Day
Date analysis concluded	2022 Year 03 Month 01 Day

Other

Other related information

(1) ALL patient 5-year survivals (2) Effect of stem sell transplantation (SCT) on ALL patients (3) Effect of timing of SCT and conditioning regimen on ALL patients (4) Numbers of patients with ALL by age group, sex and type of diseases (5) Feasibility of classification according to known prognostic factors (6) Description of patients' status in chemotherapy program (7) Remission duration due to chemotherapy

Management information
Registered date	2012 Year 04 Month 03 Day
Last modified on	2020 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008921