UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study of relapsed and refractory pediatric acute lymphoblastic leukemia
Acronym	Prospective observational study of relapse and refractory pediatric ALL
Scientific Title	Prospective observational study of relapsed and refractory pediatric acute lymphoblastic leukemia
Scientific Title:Acronym	Prospective observational study of relapse and refractory pediatric ALL
Region	Japan

Condition
Condition	acute lymphoblastic leukemia
Classification by specialty	Hematology and clinical oncology Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To accumulate clinical information prospectively of pediatric patients with relapsed or refractory acute lymphoblastic leukemia. To collect leukemia samples from patients with relapsed or refractory acute lymphoblastic leukemia for use of various basic/translational studies.
Basic objectives2	Others
Basic objectives -Others	Prospective observational study and sample collection.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	2 year EFS in all cases, in subgroups according to risk classification in 1st relapse cases, or numbers of relapse. Odd ratio in reinduction rate between clofarabine regimens and other regimens. Correlation between results (IC50 values) of in vitro drug sensitivity tests and reinduction rate.
Key secondary outcomes	2 year OS in all cases, or in subgroups according to risk classification in 1st relapse cases or numbers of relapse. 2nd progression free survival rate. Reinduction rate. Odds ratio in EFS between clofarabine regimens and other regimens. Odds ratio in OS between clofarabine regimens and other regimens. OS according to regimens or drugs used in reinduction therapy. Correlation between results (IC50 values) of in vitro drug sensitivity tests and reinduction rate in patients treated by clofarabine.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	25 years-old >
Gender	Male and Female
Key inclusion criteria	1.relapsed or refractory ALL 2.Age<18y at diagnosis and <25y at relapse. 3.Patients who have been registered in the JPLSG CHM-14 study. 4.Informed consent is necessary. 5.Not included in other JPLSG studies.
Key exclusion criteria	None
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Goto
Organization	Kanagawa Children's Medical Center
Division name	Division of Hematology/Oncology
Zip code	2328555
Address	2-138-4 Mutsukawa Minami-ku, Yokohama
TEL	045-711-2351
Email	hgotou@kcmc.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Goto
Organization	Kanagawa Children's Medical Center
Division name	Division of Hematology/Oncology
Zip code	2328555
Address	2-138-4 Mutsukawa Minami-ku, Yokohama
TEL	0457112351
Homepage URL
Email	hgotou@kcmc.jp

Sponsor
Institute	Japanese Pediatric Leukemia/Lymphoma Study Group
Institute
Department

Funding Source
Organization	Study for establishment of standard therapies in pediatric hematological cancers (lymphoid tumors)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Sanofi KK

IRB Contact (For public release)
Organization	Ethics Committee, Kanagawa Children's Medical Center
Address	2-138-4 Mutsukawa Minami-Ku, Yokohama
Tel	045-711-2351
Email	kisaka@kcmc.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 12 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	76
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	Completed
Date of protocol fixation	2015 Year 11 Month 04 Day
Date of IRB	2015 Year 11 Month 04 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2020 Year 07 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study design; prospective observational study. Subjects; Patients with relapse/refractory ALL , treated in institutions participating JPLSG Objective; To observe prognosis of patients treated according to each institutional decisions. To analyze the effect of clofarabine in reinduction regimens. data collection; disease information, reinduction regimen, results of reinduction Basic research; biobanking of relapse/refractory ALL samples. In vitro drug sensitivity test using ALL samples.

Management information
Registered date	2015 Year 11 Month 20 Day
Last modified on	2021 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022964