UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002213 |
|---|---|
| Receipt number | R000002719 |
| Scientific Title | Phase two clinical trial of limited stage lymphoblastic lymphoma. |
| Date of disclosure of the study information | 2009/07/26 |
| Last modified on | 2025/11/03 10:56:07 |
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Basic information
Public title
Phase two clinical trial of limited stage lymphoblastic lymphoma.
Acronym
Clinical trial of limited stage childhood lymphoblastic lymphoma
Scientific Title
Phase two clinical trial of limited stage lymphoblastic lymphoma.
Scientific Title:Acronym
Clinical trial of limited stage childhood lymphoblastic lymphoma
Region
| Japan |
Condition
Condition
Limited stage lymphoblastic lymphoma
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish the standard therapy in children with limited stage lymphoblastic lymphoma.
To evaluate the efficacy and safety of BFM type chemotherapy in children with limited stage lymphoblastic lymphoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
3 year event-free survival
Key secondary outcomes
(1) 3year overall survival
(2)Incidence of therapy-rerated severe toxicity
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
Treatment regimen has fundamentally BFM backbone with reinduction phase
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
| 3 | months-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Newly diagnosed patients with limited T and B cell lymphoblastic lymphoma
Key exclusion criteria
1, Down's syndrome
2, previous malignancy of any type
3, Prior stem cell or organ transplantation
4, Congenital or acquired immunodeficiency
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | shosuke |
| Middle name | |
| Last name | sunami |
Organization
Japanese Red Cross Narita Hospital
Division name
Department of Pediatrics
Zip code
2868523
Address
90-1 Iidacho Narita city Japan
TEL
0476222311
s-sunami@sc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Shosuke |
| Middle name | |
| Last name | Sunami |
Organization
Japanese Red Cross Narita Hospital
Division name
Department of Pediatrics
Zip code
2868523
Address
90-1 Iidacho Narita city Japan
TEL
0476-22-2311
Homepage URL
http://www.jplsg.jp/
s-sunami@sc4.so-net.ne.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group(JPLSG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Pediatric Leukemia/Lymphoma Study Group(JPLSG)
Address
4-1-1 Sannnomaru Naka Nagoya city
Tel
0529511111
officejp@nnh.hosp.go.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
| 2009 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
Pediatr Blood Cancer. 2025 May;72(5):e31590.
Publication of results
Published
Result
URL related to results and publications
Pediatr Blood Cancer. 2025 May;72(5):e31590.
Number of participants that the trial has enrolled
41
Results
The mean age at diagnosis was 9.2 years (range 2.1-16.1 years). Sixty-five percent of patients were male. Twenty-nine patients had a pre-B immunophenotype, and six had a pre-T immunophenotype. The head and neck area accounted for 66% of the primary sites. At a median follow-up of more than 10 years, the 3-year event-free survival rate [95% confidence interval] was 97.1% [81.4-99.6%], and the 3-year overall survival rate was 100%. Overall.
Results date posted
| 2025 | Year | 11 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age at diagnosis was 9.2 years (range 2.1-16.1 years). Sixty-five percent of patients were male. Twenty-nine patients had a pre-B immunophenotype, and six had a pre-T immunophenotype. The head and neck area accounted for 66% of the primary sites. At a median follow-up of more than 10 years, the 3-year event-free survival rate [95% confidence interval] was 97.1% [81.4-99.6%], and the 3-year overall survival rate was 100%.
Participant flow
The ethics committee of each participating institute approved the study protocol. The diagnosis of LBL was based on histopathology and immunocytochemistry. All histopathological specimens were first classified by the World Health Organization (WHO) classification by the institutional pathologist and then by seven pathologists from a central pathological review committee.
Of the 41 patients, six patients were excluded with a different diagnosis; therefore, 35 were included in the primary efficacy and safety
Adverse events
Toxicity was evaluated by the scale of National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 2.0. All, patients tolerated the therapy well, and no treatment-related deaths were observed.
Outcome measures
The primary endpoint was 3-year EFS rate. The secondary endpoints were occurrence rates of adverse events of grade 3 or higher, according to the National Cancer Institute's Common Toxicity Criteria and three-year OS rate. EFS and OS rates were evaluated using the Kaplan-Meier method.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2004 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2005 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2005 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 16 | Day |
Last modified on
| 2025 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002719
