Clinical trial NCT04067518: A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Official title: A Phase 2 Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic Leukemia
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Kirin Co., Ltd.
name: ADIR, a Servier Group company
First posted: 2019-08-26
Enrollment: 28
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The intervention study model is sequential in results section of record.
Primary purpose: TREATMENT

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 assess the safety, pharmacokinetics and efficacy of SHP674 dose in Part 2 (found to be tolerated in Part 1) in the treatment of newly diagnosed untreated acute lymphoblastic leukemia (ALL) in Japanese participants.


Eligibility criteria: 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

Primary outcomes:
measure: Part 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs During the Tolerability Assessment Period
timeFrame: Up to 30 days after last dose of study drug (approximately 49 weeks)
measure: 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
timeFrame: 14 days after the first dose of SHP674
Secondary outcomes:
measure: Percentage of Participants With Anti-Drug (SHP674) Antibody (ADA) (Part 1 and Part 2)
timeFrame: Predose and 25 days post dose (Part 1 and Part 2)
measure: Percentage of Participants With Anti-Polyethylene Glycol (PEG) Antibody (Part 1 and Part 2)
timeFrame: Predose and 25 days post dose (Part 1 and part 2)
measure: 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
timeFrame: 14 days after the first dose of SHP674
measure: Part 2: Percentage of Participants With Plasma Asparaginase Activity of ≥0.1 IU/mL or <0.1 IU/mL
timeFrame: Day 1 (pre-dose, 5 min, 4 hours, 24 hours post dose), Days 2, 4, 11, 14, 18, 25 post dose
measure: Survival Rate at 1 Year After the Start of Study Treatment
timeFrame: 1 year after the start of study treatment (from first dose up to 12 months)
measure: Event-free Survival Rate at 1 Year After the Start of Study Treatment
timeFrame: 1 year after the start of study treatment (from first dose up to 12 months)
Other outcomes:
Locations:
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital Department of Pediatrics
city: Kobe
country: Japan
facility: Kobe Children's Hospital Department of Hematology/Oncology
city: Nagoya
country: Japan
facility: Nagoya Medical Center Department of Pediatrics
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Saitama
country: Japan
facility: Saitama Children's Medical Center Department of Hematology/Oncology
city: Sapporo
country: Japan
facility: Sapporo Hokuyu Hospital Department of Pediatrics and Adolescent Medicine
city: Tokyo
country: Japan
facility: National Cancer Center Hospital Department of Pediatric Oncology
city: Tokyo
country: Japan
facility: St. Luke's International Hospital Department of Pediatrics
Study officials:
affiliation: National Cancer Center Hospital, Tokyo JAPAN
name: Chitose Ogawa, MD
role: PRINCIPAL_INVESTIGATOR
References: