UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039803 |
|---|---|
| Receipt number | R000045395 |
| Scientific Title | Special Drug Use Surveillance of Alecensa Capsules in Pediatric Patients- Recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma - |
| Date of disclosure of the study information | 2020/08/03 |
| Last modified on | 2024/01/15 14:32:12 |
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Basic information
Public title
Special Drug Use Surveillance of Alecensa Capsules in Pediatric Patients- Recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma -
Acronym
Special Drug Use Surveillance of Alecensa Capsules in Pediatric Patients- Recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma -
Scientific Title
Special Drug Use Surveillance of Alecensa Capsules in Pediatric Patients- Recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma -
Scientific Title:Acronym
Special Drug Use Surveillance of Alecensa Capsules in Pediatric Patients- Recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma -
Region
| Japan |
Condition
Condition
Recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate onset profile of adverse drug reactions and efficacy in pediatric patients in actual clinical use of Alecensa Capsules (below, Alecensa) for recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Institution information: Name of institution, name of department, date CRF completed, name of physician completing CRF
2.Patient demographics: Patient initials, age at treatment initiation, ID number, sex, reason for use of Alecensa, height, body weight, disease stage, whether recurrent or refractory, B symptoms, performance status, international prognostic index, concurrent disease, previous disease
3.History of previous treatment: Presence or absence, details of treatment, treatment duration (only for the final treatment)
4.Treatment status: Alecensa treatment status (daily dose, dosing schedule, treatment start date, treatment stop date), status at CRF completion (reason for discontinuation in patients who discontinued treatment)
5.Response assessment: Date of assessment, assessment
6.Adverse events: Presence or absence, event name, date of onset, worst grade, seriousness, action taken (Alecensa, other), outcome, date of outcome, causal relationship (Alecensa, other factors), laboratory test values
7.<In the case of serious adverse event> Concomitant suspect drug and CYP3A4 inhibitor
Key secondary outcomes
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
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatric patients with recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma
Key exclusion criteria
>14 years old at Alecensa initiation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Takemoto |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety science Dept.
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
takemotosny@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Murayama |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety Science Dept.
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
Homepage URL
murayamaayk@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
None
Address
None
Tel
None
None
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
| 2020 | Year | 08 | Month | 03 | 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
| 2020 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 03 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045395
