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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018780
Receipt No. R000021371
Scientific Title The multicenter study for purposes of detection of prognostic factor of advanced stage pediatric lymphoblastic lymphoma treated with standard chemotherapy
Date of disclosure of the study information 2015/09/01
Last modified on 2019/08/27

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Basic information
Public title The multicenter study for purposes of detection of prognostic factor of advanced stage pediatric lymphoblastic lymphoma treated with standard chemotherapy
Acronym The multicenter to detect prognostic factor of advanced stage pediatric lymphoblastic lymphoma treated with standard chemotherapy (ALB-NHL-14)
Scientific Title The multicenter study for purposes of detection of prognostic factor of advanced stage pediatric lymphoblastic lymphoma treated with standard chemotherapy
Scientific Title:Acronym The multicenter to detect prognostic factor of advanced stage pediatric lymphoblastic lymphoma treated with standard chemotherapy (ALB-NHL-14)
Region
Japan

Condition
Condition lymphoblastic lymphoma stage III / IV
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Patients under 20 years old and diagnosed as stage III / IV lymphoblastic lymphoma are enrolled in this study and are treated with one of standard chemotherapy regimen NHL-BFM95. Tumor samples are analyzed in order to detect prognostic factor and establish risk-adapted treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The ratio of cases with 6qLOH in T-cell lymphoblastic lymphoma and hazard ratio in 3-year event free survival
Key secondary outcomes The ratio of cases with positive minimal disseminated disease (MDD) in T or B-cell lymphoblastic lymphoma and each hazard ratio in 3-year event free survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients under 20 years old and diagnosed as stage III / IV lymphoblastic lymphoma are enrolled in this study and are treated with one of standard chemotherapy regimen NHL-BFM95.
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
0 years-old <=
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria (1) diagnosis of precursor T-cell lymphoblastic lymphoma or precursor B-cell lymphoblastic lymphoma (ratio of blast in bone marrow is less than 25%)
(2) diagnosis of stage III/IV disease
(3) age under 20 year old at diagnosis
(4) registration at JPLSG CHM-14 study
(5) no history of previous anti-cancer therapy except listed below ;
a) biopsy or surgical resection
b) emergency irradiation therapy within 7days
c) prednisolone therapy within 7 days
d) VCR or DNR therapy within 7 days in order to improve severe dyspnea
(6) ECOG performance status (PS) score of 0-2, or worsening to 4 due to lymphoma
(7) sufficient hepatic and renal function satisfying the laboratory data listed below ;
a) T-Bili: within 3x of age adjusted upper-limit of normal range.
b) Creatinine: within 3x of age adjusted upper-limit of normal range.
(8) observation for at least 3 years after biginning treatment
(9) written informed consent obtained from patient or guardians.
Key exclusion criteria (1) Down syndrome.
(2) Other previous illness of malignant tumor or previous therapy of organ transplantation including hematopoietc stem cells.
(3) history of congenital or acquired immunodeficiency.
(4) uncontrolled infection, including active tuberculosis infection and positive of HIV antibody.
(5) pregnancy or high possibility of pregnancy and giving suck woman.
(6) QTfc, corrected by Friderics formula as QTfc = QT/RR*1/3, is more than 0.45 seconds.
(7) CNS hemorrage more than grade 3 of CACAE v4.0
(8) MDS, Ph1 positive
(9) any inappropriate status judged by
physician.
Target sample size 145

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Mori
Organization Kobe University Hospital
Division name Department of Pediatrics
Zip code 6500017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
TEL 078-382-5111
Email alb14@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Mori
Organization Kobe University Hospital
Division name Department of Pediatrics
Zip code 6500017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
TEL 078-382-5111
Homepage URL http://jplsg.jp/index.htm
Email alb14@med.kobe-u.ac.jp

Sponsor
Institute Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
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 Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Grant from the National Center for Child Health and Development

IRB Contact (For public release)
Organization Kobe University Hospital Clinical and Translational Research Center
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
Tel 078-382-6669
Email rinri@med.kobe-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

Other administrative information
Date of disclosure of the study information
2015 Year 09 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
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 Open public recruiting
Date of protocol fixation
2015 Year 07 Month 22 Day
Date of IRB
2015 Year 07 Month 27 Day
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2024 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 24 Day
Last modified on
2019 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021371

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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