UMIN-CTR Clinical Trial

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	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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018972