UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032249 |
|---|---|
| Receipt number | 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 | 2024/04/17 09:45:11 |
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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 | Takahiko |
| Middle name | |
| Last name | Hara |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Stem cell project
Zip code
16-8506
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
TEL
03-5316-3310
hara-tk@igakuken.or.jp
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Hara |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Stem cell project
Zip code
156-8506
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
TEL
03-5316-3310
Homepage URL
hara-tk@igakuken.or.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
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
Tokyo Metropolitan Institute of Medical Science
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
Tel
03-5316-3310
hara-tki@igakuken.or.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/cas.15918
Number of participants that the trial has enrolled
3
Results
We performed large-scale screening of natural compound libraries to identify potential drugs against T-ALL. We identified three low-molecular-weight compounds that inhibited the proliferation of the T-ALL cell line CCRF-CEM, but not that of the B lymphoma cell line Raji in a low concentration range. Among them, Auxarconjugatin-B suppressed the in vitro growth of five human T-ALL cell lines and two T-ALL patient-derived cells. These compounds are promising seeds for developing novel anti-T-ALL drugs.
Results date posted
| 2024 | Year | 04 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 07 | Month | 31 | Day |
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
| 2015 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036775
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