UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012119 |
|---|---|
| Receipt number | R000014174 |
| Scientific Title | Clinical evaluation of Asparagine Synthetase (ASNS) Level in Leukemia/ Lymphoma Cells by Monoclonal Antibodies |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2019/06/21 17:43:47 |
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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
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
tkitoh@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014174
