UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007869 |
|---|---|
| Receipt number | R000009271 |
| Scientific Title | Evaluation of safety in the ethical use of erwininia L-asparaginase (erwinase) for patients with acute lymphoblastic leukemia and lymphoblastic lymphoma |
| Date of disclosure of the study information | 2012/05/01 |
| Last modified on | 2012/05/01 12:56:38 |
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Basic information
Public title
Evaluation of safety in the ethical use of erwininia L-asparaginase (erwinase) for patients with acute lymphoblastic leukemia and lymphoblastic lymphoma
Acronym
Evaluation of safety in the ethical use of erwininia L-asparaginase (erwinase)
Scientific Title
Evaluation of safety in the ethical use of erwininia L-asparaginase (erwinase) for patients with acute lymphoblastic leukemia and lymphoblastic lymphoma
Scientific Title:Acronym
Evaluation of safety in the ethical use of erwininia L-asparaginase (erwinase)
Region
| Japan |
Condition
Condition
Acute lymphoblastic leukemia, lymphoblastic lymphoma
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety in the use of erwinia L-asparaginase (erwinase) for patients with acute lymphoblastic leukemia and lymphoblastic lymphoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The frequency and the severity of adverse events
Key secondary outcomes
The efficacy of the drug evaluating the remission status
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The use of the predefined dosage of erwinia L-asparaginase (erwinase)
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
| 0 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Previously registered in the OP-01 trial.
2. The disease is in remission.
3. At least 14 days passed after the last administration of anticancer drugs.
4. Performance status equal or greater than 50 points.
5. No major visceral organ insufficiency.
Key exclusion criteria
1. Patients who had adverse events with the previous use of erwinase.
2. Having the following complications:
(1) Infection requiring systemic antibiotics.
(2) Herat diseases.
(3) Interstitial pneumonitis or pulmonary fibrosis
(4) Down syndrome
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Manabe |
Organization
St. Luke's International Hospital
Division name
Department of Pediatrics
Zip code
Address
9-1, Akashi-cho, Chuo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Children's Cancer Study Group (TCCSG)
Division name
Executive office
Zip code
Address
TEL
03-3547-3330
Homepage URL
manabe-luke@umin.ac.jp
Sponsor or person
Institute
Tokyo Children's Cancer Study Group (TCCSG)
Institute
Department
Personal name
Funding Source
Organization
Multiinstitutional clinical trials to establish standard treatment strategies for children with cancer (23-A-24): Atushi Makimoto as a principal investigator
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | 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
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
| 2012 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 01 | Day |
Last modified on
| 2012 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009271
| 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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