UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016346
Receipt No. 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 2019/08/16

* 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 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
Email 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
Email tmitsui@med.id.yamagata-u.ac.jp

Sponsor
Institute Japan children's cancer group.
Institute
Department

Funding Source
Organization Japan agency for medical research and development.
Division of cancer research.
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 The ethics committee of Yamagata University, Faculty of Medicine
Address 2-2-2 yamagata-city, Yamagata, Japan
Tel 023-628-5047
Email 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
2025 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
2019 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018972

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.