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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032249
Receipt No. R000036775
Scientific Title Examination of the growth suppressive effect of chemical compounds against T cell acute lymphoblastic leukemia (T-ALL) cells
Date of disclosure of the study information 2018/04/16
Last modified on 2018/04/14

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Basic information
Public title Examination of the growth suppressive effect of chemical compounds against T cell acute lymphoblastic leukemia (T-ALL) cells
Acronym Development of the growth suppressive compounds against T-ALL
Scientific Title Examination of the growth suppressive effect of chemical compounds against T cell acute lymphoblastic leukemia (T-ALL) cells
Scientific Title:Acronym Development of the growth suppressive compounds against T-ALL
Region
Japan

Condition
Condition T cell acute lymphoblastic leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 T-cell acute lymphoblastic leukemia (T-ALL) is a relatively rare leukemia with poor prognosis, and there is no efficient drug. We performed large-scale screening of natural compound libraries to find out a compound that suppresses the proliferation of T-ALL cell line CCRF-CEM, but does not inhibit the growth of B lymphoma cell line Raji. Among 150000 different compounds, we successfully identified 3 low-molecular-weight compounds (44D-L008, 31D-F005, 21D-D016) that fulfilled the above criteria. 44D-L008 and 31D-F005 possessed a common chemical structure. In the presence of 5 micro M of 31D-F005, proliferation of 5 human T-ALL cell lines including CCRF-CEM was severely blocked. On the other hand, Raji, oral carcinoma-derive cell line HSC-3, osteosarcoma-derived cell line Saos-2 were completely resistant to 5 micro M of 31D-F005 in the same experimental settings. Thus, 31D-F005 is promising as a lead compound for developing novel anti-T-ALL drugs. In this study, we explore whether 31D-F005 and its chemical derivatives efficiently suppress the in vitro growth of T-ALL patient-derived primary cancer cells.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In vitro cell growth-suppressing activity
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria T-ALL
Key exclusion criteria non T-lineage leukemia
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiko Hara
Organization Tokyo Metropolitan Institute of Medical Science
Division name Stem cell project
Zip code
Address 2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
TEL 03-5316-3310
Email hara-tk@igakuken.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiko Hara
Organization Tokyo Metropolitan Institute of Medical Science
Division name Stem cell project
Zip code
Address 2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
TEL 03-5316-3310
Homepage URL
Email hara-tk@igakuken.or.jp

Sponsor
Institute Japan Agency for Medical Research and Development
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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 04 Month 16 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 Enrolling by invitation
Date of protocol fixation
2015 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Dose and time for the full growth-suppressing activity are recorded.

Management information
Registered date
2018 Year 04 Month 14 Day
Last modified on
2018 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036775

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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