UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016346 |
|---|---|
| Receipt number | R000018972 |
| Scientific Title | Dexamethasone, ifosfamide, carboplatin, and etoposide in treating patients with refractory lymphoblastic lymphoma. |
| Date of disclosure of the study information | 2015/02/14 |
| Last modified on | 2022/08/02 16:49:26 |
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Basic information
Public title
Dexamethasone, ifosfamide, carboplatin, and etoposide in treating patients with refractory lymphoblastic lymphoma.
Acronym
DexICE therapy for refractory LBL
Scientific Title
Dexamethasone, ifosfamide, carboplatin, and etoposide in treating patients with refractory lymphoblastic lymphoma.
Scientific Title:Acronym
DexICE therapy for refractory LBL
Region
| Japan |
Condition
Condition
Lymphoblastic lymphoma
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Vertification of efficacy and safety of dexamethasone, ifosfamide, carboplatin, and etoposide in treating patients with refractory lymphoblastic lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Complete and partial remission rate.
Key secondary outcomes
Event free and overall survival at 2-year. Proportion of adverse events and attainment rate for allogeneic blood stem cell transplantation. Searching for correlation between minimal marrow and blood disseminated disease with prognosis. Searching for specific tumor gene character in refractory LBL through gene profiling assay.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vertification of efficacy and safety of dexamethasone, ifosfamide, carboplatin, and etoposide in treating patients with refractory or first relapsed lymphoblastic lymphoma.
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
| 1 | years-old | <= |
Age-upper limit
| 19 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Lymphoblastic lymphoma according to 2007 WHO classification through pathological assay.
2) Progressive or recurrent stage III/IV disease without central nervous infiltration.
3) Above 1-year old at initial diagnosis and under 20-year old at registry.
4) Adequate organ function with meeting safety laboratory criteria those listed following, excluding conditions caused by a tumor.
Total bilirubin below 3.1 mg/dl.
Serum creatinine level below 0.81 mg/dl(under 5-year old),
Below 1.21 (5-9 year)
Below 1.5 (above 9 year)
Without arrhythmia and QT prolongation under medication.
Ejection fraction above 49% and fractional shortening above 24% in echocardiogram of heart.
5) Agreement by a document for participation of this clinical trial.
Key exclusion criteria
1) Down syndrome.
2) Existence of CNS infiltration.
3) Philadelphia chromosome positive disease.
4) Myelodysplastic syndromes.
5) Other previous illness of malignant tumor.
6) Previous therapy of organ transplantation including blood stem cells.
7) Previous illness of congenital and HIV related immunodeficiency.
8) Additional status that a doctor in charge judges to be improper.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Mitsui |
Organization
Yamagata University, Faculty of Medicine.
Division name
Department of Pediatrics.
Zip code
9909575
Address
2-2-2 Yamagata-shi, Yamagata, Japan 990-9575
TEL
023-628-5329
tmitsui@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuo |
| Middle name | |
| Last name | Mitsui |
Organization
Yamagata University Hospital
Division name
Pediatrics
Zip code
9909575
Address
2-2-2 Yamagata-shi, Yamagata, Japan 990-9575
TEL
023-628-5329
Homepage URL
http://jplsg.jp/index.htm
tmitsui@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Japan children's cancer group.
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Transplantation and Cellular Therapy
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japan Society for the Promotion of Science
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Yamagata University, Faculty of Medicine
Address
2-2-2 yamagata-city, Yamagata, Japan
Tel
023-628-5047
ikekenkyu@jm.kj.yamagata-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
国内JPLSG研究参加施設, JCCG参加施設
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 14 | 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 | 01 | Month | 16 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
ALB-R13 clinical trial migrated into under control of the Clinical Trial Act from April 2019.
Management information
Registered date
| 2015 | Year | 01 | Month | 26 | Day |
Last modified on
| 2022 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018972
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
