UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010566 |
|---|---|
| Receipt number | 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 19:28:25 |
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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
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/
igurin66@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011828
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
