Status:
COMPLETED
A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Lead Sponsor:
Institut de Recherches Internationales Servier
Collaborating Sponsors:
Kyowa Kirin Co., Ltd.
ADIR, a Servier Group company
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-21 years
Phase:
PHASE2
Brief Summary
The objectives of the study are to assess the safety and tolerability of a single dose of SHP674 in Japanese participants (dose confirmation) in the tolerability assessment period of Part 1 and to ass...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2022
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04067518
Start Date
October 17 2019
End Date
February 4 2022
Last Update
April 20 2023
Active Locations (8)
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1
Kagoshima University Hospital Department of Pediatrics
Kagoshima, Japan
2
Kobe Children's Hospital Department of Hematology/Oncology
Kobe, Japan
3
Nagoya Medical Center Department of Pediatrics
Nagoya, Japan
4
Niigata Cancer Center Hospital
Niigata, Japan