UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057386 |
|---|---|
| Receipt number | R000065570 |
| Scientific Title | Prospective Observational Study of L-Asparaginase Activity and Antibody Changes after Introduction of PEGylated L-Asparaginase for Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children, AYA, and Adults |
| Date of disclosure of the study information | 2025/03/24 |
| Last modified on | 2025/09/22 09:06:15 |
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Basic information
Public title
Prospective Observational Study of L-Asparaginase Activity and Antibody Changes after Introduction of PEGylated L-Asparaginase for Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children, AYA, and Adults
Acronym
PEG-ASP24
Scientific Title
Prospective Observational Study of L-Asparaginase Activity and Antibody Changes after Introduction of PEGylated L-Asparaginase for Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children, AYA, and Adults
Scientific Title:Acronym
PEG-ASP24
Region
| Japan |
Condition
Condition
Acute lymphoblastic leukemia (ALL) or malignant lymphoma-including lymphoblastic lymphoma (LBL)-regardless of whether newly diagnosed or recurrent.
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate the real-world data of silent inactivation (SI) in Japan since the introduction of polyethylene glycol-ASP preparation (PEG-ASP) for ALL/LBL and establish a future standard of care, the frequency of SI in PEG-ASP-treated patients will be evaluated in an exploratory manner.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of SI in PEG-ASP-treated cases
Key secondary outcomes
1)Frequency of SI in all cases treated with ASP products derived from E. coli (including native E. coli-ASP) since the introduction of PEG-ASP
2)Frequency of anti-L-ASP antibody production in Japan since the introduction of PEG-ASP
3)Proportion of cases with an L-ASP activity of <0.1 U/mL on day 21 after PEG-ASP administration
4)Frequency of allergic reactions and anaphylaxis for each formulation in cases treated with PEG-ASP, native E.coli-ASP, and Erw-ASP
5)Frequency of occurrence of decreased L-ASP activity and frequency of allergic reactions and anaphylaxis by age group
6)Changes in L-ASP activity and antibody titers before L-ASP formulation changes and after the last Erw-ASP dose due to allergic reactions and anaphylaxis
7)Correlation between the presence of anti-L-ASP antibodies and allergic reactions and anaphylaxis (CTCAE ver5.0)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ALL or malignant lymphoma, including LBL, who are receiving treatment with L-ASP and meet one of the following inclusion criteria while not meeting any of the following exclusion criteria
Inclusion criteria:
1)Patients provided written consent to participate in the PEG-ASP24 study if they were 16 years of age or older, or consent was obtained from a legal guardian if the patient is younger. Recurrent cases are also eligible to participate. Regarding T-ALL cases, patients enrolled in the ALL-T19 study who have discontinued study treatment will be eligible (T-ALL in non-ALL-T19 enrolled cases will also be eligible).
2)If a patient meets (1) of the abovementioned criteria and is changing from PEG-ASP (or native E. coli-ASP) to Erw-ASP owing to allergic reaction or anaphylaxis, and if a patient has a blood sample for L-ASP activity and antibody measurement after the last dose of PEG-ASP (or native E. coli-ASP), the patient will be allowed to participate from that time onward.
Key exclusion criteria
1)The principal investigator or research physician determines that participation in the PEG-ASP24 study is not appropriate.
2)Patients enrolled in the ALL-T19 trial with ongoing study treatment.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ishihara |
Organization
Nara Medical University
Division name
Department of Pediatrics
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
takakun@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ishihara |
Organization
Nara Medical University
Division name
Department of Pediatrics
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
takakun@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Takashi Ishihara
Funding Source
Organization
Nihon Servier Co., Ltd., Tokyo, Japan and OHARA Pharmaceutical Co., Ltd., Koka, Shiga, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University Ethics Committee
Address
840 Shijo-cho, Kashihara, Nara
Tel
0744-22-3051
ino_rinri@naramed-u.ac.jp
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
| 2025 | Year | 03 | Month | 24 | 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
| 2024 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Study design:
A multi-institutional prospective cohort study conducted as an observational study, not an intervention
Study duration:
Research period: from the date of approval to March 31, 2028
Enrollment period: from the date of approval to March 31, 2027 (approximately 2 years)
Analysis period: from the date of approval to March 31, 2028 (approximately 3 years)
Planned number of cases:
A total of 150 cases annually, 300 cases in total (approximately 2 years)
Management information
Registered date
| 2025 | Year | 03 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065570
