UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027990
Receipt No. R000032057
Scientific Title Proteasome inhibitor for relapsed pediatric acute lymphoblastic leukemia following allogeneic stem cell transplantation
Date of disclosure of the study information 2017/06/30
Last modified on 2017/06/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Proteasome inhibitor for relapsed pediatric acute lymphoblastic leukemia following allogeneic stem cell transplantation
Acronym Proteasome inhibitor for relapsed pediatric acute lymphoblastic leukemia following HCT
Scientific Title Proteasome inhibitor for relapsed pediatric acute lymphoblastic leukemia following allogeneic stem cell transplantation
Scientific Title:Acronym Proteasome inhibitor for relapsed pediatric acute lymphoblastic leukemia following HCT
Region
Japan

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

Objectives
Narrative objectives1 To provide a therapy effective against a case of relapsed pediatric acute lymphoblastic leukemia following HCT that can extend a life prognosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Hematological remission on day 29
Key secondary outcomes Examination of safety based on CTCAE ver. 4.0 on day 29

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bortezomib, (1.3mg/m2) : day 1, 4, 8, 11
Vincristine, (1.5mg/m2): day 1, 8, 15, 22
Doxorubicin, (60mg/m2): day 1
Dexamethasone, (10mg/m2/day): day 1-14
L-asparaginase, (10000U/m2): day 2, 5, 8, 11, 15, 18, 22, 25
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
2 years-old <=
Age-upper limit
2 years-old >
Gender Male
Key inclusion criteria No active infection, performance status is required for more than 50 on Lansky score is eligible.
Key exclusion criteria Not meeting the requirement the above is excluded.
Target sample size 1

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nibuyuki Hyakuna
Organization University of Ryukyus, Hospital
Division name Department of Pediatrics
Zip code
Address Uehara 207, Nishihara cho, Okinawa
TEL 098-895-3331
Email hyakunan@med.u-ryukyu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Hamada
Organization University of Ryukyus, Hospital
Division name Department of Pediatrics
Zip code
Address Uehara 207, Nishihara cho, Okinawa
TEL 098-895-3331
Homepage URL
Email shamada@med.u-ryukyu.ac.jp

Sponsor
Institute University of Ryukyus, Hospital
Institute
Department

Funding Source
Organization University of Ryukyus, Hospital
Organization
Division
Category of Funding Organization Other
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
2017 Year 06 Month 30 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 29 Day
Last modified on
2017 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032057

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.