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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010566
Receipt No. R000011828
Scientific Title Clinical trial to evaluate the safety of Bortezomib combined with chemotherapy in children with refractory childhood acute lymphoblastic leukemia
Date of disclosure of the study information 2013/04/23
Last modified on 2016/04/25

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Basic information
Public title Clinical trial to evaluate the safety of Bortezomib combined with chemotherapy in children with refractory childhood acute lymphoblastic leukemia
Acronym Clinical trial to evaluate the safety of Bortezomib combined with chemotherapy in children with refractory childhood acute lymphoblastic leukemia
Scientific Title Clinical trial to evaluate the safety of Bortezomib combined with chemotherapy in children with refractory childhood acute lymphoblastic leukemia
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Akihiro Iguchi
Organization Hokkaido University Hospital
Division name Pediatrics
Zip code
Address N14W5 Kita-ku, Sapporo city
TEL 011-706-5954
Email igurin66@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Iguchi
Organization Hokkaido University Hospital
Division name Pediatrics
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol http://www.huhp.hokudai.ac.jp/patient/clinical/clinical.html
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 Completed
Date of protocol fixation
2012 Year 12 Month 17 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000011828

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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