- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04067518
A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
A Phase 2 Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Kagoshima, Japan
- Kagoshima University Hospital Department of Pediatrics
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Kobe, Japan
- Kobe Children's Hospital Department of Hematology/Oncology
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Nagoya, Japan
- Nagoya Medical Center Department of Pediatrics
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Niigata, Japan
- Niigata Cancer Center Hospital
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Saitama, Japan
- Saitama Children's Medical Center Department of Hematology/Oncology
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Sapporo, Japan
- Sapporo Hokuyu Hospital Department of Pediatrics and Adolescent Medicine
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Tokyo, Japan
- National Cancer Center Hospital Department of Pediatric Oncology
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Tokyo, Japan
- St. Luke's International Hospital Department of Pediatrics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 1 to ≤21 years at the time of informed consent;
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2;
- Newly diagnosed, untreated precursor B-cell ALL
- No prior therapy for malignant tumor such as chemotherapy and radiation therapy before signing the informed consent;
- Life expectancy of at least 6 months from the date of enrollment;
Exclusion Criteria:
- Mature B-cell ALL ; Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL
- Preexisting known coagulopathy ;
- History of pancreatitis;
- Continuous use of corticosteroids;
- Prior treatment or possible prior treatment with an L-asparaginase preparation;
- History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs;
- Pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SHP674
Part 1: Participants with ALL who were stratified into the standard risk (SR) or intermediate risk (IR) groups received total 3 doses of SHP674 in the 36-week treatment period and who were stratified into the high risk (HR) group received total 8 doses of SHP674 in the 45-week treatment period. Part 2: Participants with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674 in the 41-week treatment period and who were stratified into the HR group received total 8 doses of SHP674 in the 45-week treatment period. |
SHP674: powder for solution for injection, IV (administered by 1 to 2 hours of drip infusion), dose determination : if BSA ≥0.6 m^2: 2500 IU/m^2 every 14 days if BSA <0.6 m^2: 82.5 IU/kg every 14 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 2: Percentage of Participants Who Achieved a Plasma Asparaginase Activity of ≥0.1 International Units Per Milliliter (IU/mL) 14 Days (336 Hours) After the First Dose of SHP674
Time Frame: 14 days after the first dose of SHP674
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14 days after the first dose of SHP674
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Part 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs During the Tolerability Assessment Period
Time Frame: Up to 30 days after last dose of study drug (approximately 49 weeks)
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An adverse event (AE) is defined as any untoward medical occurrence in a participant after signing informed consent.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease, whether or not it is related to the investigational product.
TEAE is defined as any untoward medical occurrence in a participant who received an investigational product which occurs during the period from Day 1 of the pre-treatment phase to 30 (+7) days after the last dose of investigational product, or until the start of a new therapy, whichever occurs first.
A related adverse event signifies that there is a reasonable causal relationship between study treatment and an AE.
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Up to 30 days after last dose of study drug (approximately 49 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1: Percentage of Participants Who Achieved a Plasma Asparaginase Activity of ≥0.1 IU/mL 14 Days (336 Hours) After the First Dose of SHP674
Time Frame: 14 days after the first dose of SHP674
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14 days after the first dose of SHP674
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Part 2: Percentage of Participants With Plasma Asparaginase Activity of ≥0.1 IU/mL or <0.1 IU/mL
Time Frame: Day 1 (pre-dose, 5 min, 4 hours, 24 hours post dose), Days 2, 4, 11, 14, 18, 25 post dose
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Day 1 (pre-dose, 5 min, 4 hours, 24 hours post dose), Days 2, 4, 11, 14, 18, 25 post dose
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Survival Rate at 1 Year After the Start of Study Treatment
Time Frame: 1 year after the start of study treatment (from first dose up to 12 months)
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Survival rate is defined as the percentage of subjects who survived at 1 year after the start of study treatment.
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1 year after the start of study treatment (from first dose up to 12 months)
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Event-free Survival Rate at 1 Year After the Start of Study Treatment
Time Frame: 1 year after the start of study treatment (from first dose up to 12 months)
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Event-free survival rate is defined as percentage of subjects who did not experience any event and survived at 1 year after the start of study treatment.
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1 year after the start of study treatment (from first dose up to 12 months)
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Percentage of Participants With Anti-Drug (SHP674) Antibody (ADA) (Part 1 and Part 2)
Time Frame: Predose and 25 days post dose (Part 1 and Part 2)
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Predose and 25 days post dose (Part 1 and Part 2)
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Percentage of Participants With Anti-Polyethylene Glycol (PEG) Antibody (Part 1 and Part 2)
Time Frame: Predose and 25 days post dose (Part 1 and part 2)
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Predose and 25 days post dose (Part 1 and part 2)
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Collaborators and Investigators
Investigators
- Principal Investigator: Chitose Ogawa, MD, National Cancer Center Hospital, Tokyo JAPAN
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHP674-201/CL1-95014-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Qualified scientific and medical researchers can request access to anonymized participant-level and study-level clinical trial data.
Access can be requested for all interventional clinical studies:
- used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
- where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.
In addition, access can be requested for all interventional clinical studies in participants:
- sponsored by Servier
- with a first participant enrolled as of 1 January 2004 onwards
- for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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