UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018780 |
|---|---|
| Receipt number | 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 | 2023/02/28 10:28:19 |
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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
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
alb14@med.kobe-u.ac.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
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
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
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
92
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
No longer 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
| 2023 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021371
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| Registered date | File name |
| Research case data | |
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