UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial to evaluate the safety of Bortezomib combined with chemotherapy in children with refractory childhood acute lymphoblastic leukemia
Title of the study (Brief title)	Clinical trial to evaluate the safety of Bortezomib combined with chemotherapy in children with refractory childhood acute lymphoblastic leukemia
Region	Japan

Condition
Condition	refractory childhood acute lymphoblastic leukemia
Classification by specialty	Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	the safety of Bortezomib combined with chemotherapy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	dose limiting toxicity (DLT) according to CTCAE4 beyond grade 3 except for blood system disorder
Key secondary outcomes	1. toxicities except for DLT 2. treatment response rates 3. rate of complete remission 4. event free survival for 4 months

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Bortezomib combined with chemotherapy (TACL regimen)
Interventions/Control_2	Bortezomib combined with chemotherapy (UK-R3 regimen)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	1 years-old <=
Age-upper limit	20 years-old >
Gender	Male and Female
Key inclusion criteria	1.patients with first induction failure (receving different two or more treatments, or childhood ALL (B precursor and T cell type except for relapse of extramedullary alone beyond first relapse). 2. patients in acknowledgment of the leukaemic cells more than 25% in marrow. 3. The patients of 1 year old or older and under 18 years old at the time of the first diagnosis, and below 20 years old at the time of registration of this study 4.The patients that Eastern Cooperative Oncology Score (ECOG) performance status(PS) score of the United States is 0-2 at the time of registration. 5.The patients whom it passes more than two weeks at the time of registration after lasttreatment and the patienss who resolved treatment (except the steroid) related toxicities except for myelosuppression. 6. The patients after 6 months or more following stem cell transplantation and no active GVHD at registration. In addition, it is necessary for the immunosuppressive drugs to be decreasing in the patients who are using the drugs. 7.The patient who meets all the following standards having enough livers, kidneys, cardiac function. The inspection level assumes it a value within 14 days from registration day. 2.0 mg/dl of serum total bilirubin levels or less More than 70 creatinine clearance ml/min/1.73m2 no abnormality needing treatment with an electrocardiogram 8.the patients whose agreement is provided in a document about the participation in this clinical trial from person themselves or parents (when subject is 16 years or older person themselves and parents).
Key exclusion criteria	1. patients of Ph1-positive ALL which never receives treatment with tyrosine kinase inhibitor(TKI). 2.patients with Down syndrome. 3.patients with central nerve bleeding and the leukoencephalopathy more than CTCAE ver3.0 Grade3 affecting treatment accomplishment. 4.patients who had the past histories such as epilepsy, Guillain-Barre syndrome, and encephalitis. patients who have intractable epilepsy. 5.patients with uncontrolable infectious disease (including active tuberculosis and HIV infection) 6.patients during the pregnancy or patients who may be pregnant. 7.patients who had the past histories such as congenital or acquired immune deficiency 8. patients whom higher than one of the drugs included in this treatment plan cannot use by past treatment at all. 9.patient who had the past history of more than grade 2 peripheral neuropathy according to CTCAE ver4.0. 10.patients with allergy to mannitol and boron. 11.patients who received anthracyclines more than 350 mg/m2 by doxorubicin conversion in the past. 12.patients who had the past history of treatment-related interstitial pneumonia. Or patients with the abnormal interstitial shadow at the time of start of this study in CT. 13. patients who complicated with a second cancer other than recurrence ALL. 14.In addition, when physicians judge that it is inappropriate that the medical attendant participates in this clinical trial.
Target sample size	6

Research contact person
Name of lead principal investigator	Akihiro Iguchi
Organization	Hokkaido University Hospital
Division name	Pediatrics
Address	N14W5 Kita-ku, Sapporo city
TEL	011-706-5954
Email	igurin66@med.hokudai.ac.jp

Public contact
Name of contact person	Akihiro Iguchi
Organization	Hokkaido University Hospital
Division name	Pediatrics
Address	N14W5 Kita-ku, Sapporo city
TEL	011-707-5954
Homepage URL	http://www.hucc.hokudai.ac.jp/~e20678/
Email	igurin66@med.hokudai.ac.jp

Sponsor
Institute	Department of Pediatrics, Hokkaido University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Clinical Trials Core Hospitals project
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

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	北海道大学病院

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 17 Day
Anticipated trial start date	2013 Year 03 Month 18 Day
Last follow-up date	2016 Year 07 Month 31 Day
Date of closure to data entry	2016 Year 07 Month 31 Day
Date trial data considered complete	2016 Year 07 Month 31 Day
Date analysis concluded	2016 Year 10 Month 31 Day

Related information
URL releasing protocol	http://www.huhp.hokudai.ac.jp/patient/clinical/clinical.html
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 04 Month 23 Day
Last modified on	2016 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011828