UMIN-CTR Clinical Trial

Basic information
Public title	Clinical evaluation of Asparagine Synthetase (ASNS) Level in Leukemia/ Lymphoma Cells by Monoclonal Antibodies
Acronym	ASNS in Leukemia/Lymphoma
Scientific Title	Clinical evaluation of Asparagine Synthetase (ASNS) Level in Leukemia/ Lymphoma Cells by Monoclonal Antibodies
Scientific Title:Acronym	ASNS in Leukemia/Lymphoma
Region	Japan North America Europe

Condition
Condition	Leukemia/Lymphoma
Classification by specialty	Hematology and clinical oncology Pediatrics Laboratory medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Flow Cytometric Detection of Asparagine Synthetase (ASNS) Protein deficiency in Leukemia Cells, which is considered to be an reliable marker for indication of L-Asparaginase Therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of the effectiveness of flow cytometric estimation of ASNS Level in Leukemia/ Lymphoma or Suspension Cells by this Monoclonal Antibody.
Key secondary outcomes	To make sure that leukemia cells with low ASNS expression are sensitive to L-asparaginase in vitro MTT/WST-1 assay.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with leukemia, multiple myeloma or malignant lymphoma who are refractory to/relapsed after one or more prior chemotherapies 2)Patients whose malignant cells are collected in bone marrow blood, or peripheral blood. 3) Patients with ECOG PS 0-1 4)Patients with adequate liver function: AST <2.5x ULN, ALT <2.5x ULN, T-Bil <2x ULN (except for disease activity) 5)Patients with adequate renal function: GFR >50 ml/min 6)Patients with adequate pulmonary function: %VC >80%, FEV1.0/FVC >70% 7)Patients with adequate cardiac function: EF >50% (assessed on cardiac ultrasonography)
Key exclusion criteria	1) Patients with concomitant active cancer 2) Patients with active viral hepatitis or HBs-Ag positive 3) Patients with known CNS involvement of the lymphoma 4) Patients with previous serious allergy to any of the drugs given 5) Patients with abnormalities in cardiac function or clinically significant heart disease such as acute myocardial infarction or unstable angina within 6 months prior to the start of study treatment, heart failure NYHA class III or IV, uncontrolled hypertension or poor compliance of antihypertensive treatment, uncontrolled arrhythmias 6) Patients with serious or uncontrolled medical condition such as uncontrolled diabetes, uncontrolled active infection, significant cerebrovascular disease or poorly controlled psychiatric disease 7) Patients unable to give written informed consent 8) Others: Inappropriate patients determined by a principal investigator or sub-investigators
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Toshiyuki Middle name Last name Kitoh
Organization	Aichi Medical University Hospital
Division name	Pediatrics
Zip code	480-1195
Address	1-1 Yazako Karimata, Nagakute 480-1195
TEL	0561-62-3311
Email	tkitoh@aichi-med-u.ac.jp

Public contact
Name of contact person	1st name Toshiyuki Middle name Last name Kitoh
Organization	Aichi Medical University Hospital
Division name	Pediatrics
Zip code	480-1195
Address	1-1 Yazako Karimata, Nagakute 480-1195
TEL	0561-62-3311
Homepage URL
Email	tkitoh@aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University
Institute
Department

Funding Source
Organization	JSPS KAKENHI Grant Number 24590713
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of Transfusion Medicine, Aichi Medical University Hospital Department of Clinical Pathology, Aichi Medical University Hospital Department of Hematology, Aichi Medical University Advanced Medical Research Center, Aichi Medical University Department of Quantitative Biology and Medicine, Research Center for Advanced Science and Technology, the University of Tokyo
Name of secondary funder(s)	Institute of Immunology Co., Ltd, Japan

IRB Contact (For public release)
Organization	IRB, Aichi Medical University
Address	1-1 Yazako Karimata, Nagakute
Tel	0561-62-3311
Email	soumu@aichi-med-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

愛知医科大学病院（愛知県）Aichi Medical University Hospital (Aichi) 浜松医科大学（静岡県）Hamamatsu University School of Medicine (Shizuoka) 埼玉県立小児医療センター（埼玉県）Saitama Childrens’ Medical Center (Saitama) 群馬県立小児医療センター（群馬県）Gumma Childrens' Medical Center (Shibukawa) 静岡県立こども病院（静岡県）Shizuoka Children's Hospital (Shizuoka) 三重大学小児科（三重県）Department of Pediatrics Mie University Hospital(Mie) 都立小児総合医療センター(東京都) Tokyo Metropolitan Children's Medical Center (Tokyo) 新潟大学小児科（新潟県）Niigata University Hospital(Niigata)

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 01 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	30
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	NEED TO FOLLOW UP
Date of the first journal publication of results	2019 Year 10 Month 15 Day
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 06 Month 05 Day
Date of IRB	2012 Year 06 Month 01 Day
Anticipated trial start date	2012 Year 07 Month 19 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2019 Year 09 Month 30 Day

Other
Other related information	Result in ASNS expression dose not determined the treatment regimen.

Management information
Registered date	2013 Year 10 Month 25 Day
Last modified on	2019 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014174