A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

A Phase 2 Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04067518
• Other study ID #: SHP674-201/CL1-95014-001
• Status: Completed
• Phase: Phase 2
• Start date: October 17, 2019
• Est. completion date: February 4, 2022

Study information

• Verified date: March 2023
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 4, 2022
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• SHP674
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

Locations

Country	Name	City	State
Japan	Kagoshima University Hospital Department of Pediatrics	Kagoshima
Japan	Kobe Children's Hospital Department of Hematology/Oncology	Kobe
Japan	Nagoya Medical Center Department of Pediatrics	Nagoya
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Saitama Children's Medical Center Department of Hematology/Oncology	Saitama
Japan	Sapporo Hokuyu Hospital Department of Pediatrics and Adolescent Medicine	Sapporo
Japan	National Cancer Center Hospital Department of Pediatric Oncology	Tokyo
Japan	St. Luke's International Hospital Department of Pediatrics	Tokyo

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier	ADIR, a Servier Group company, Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs During the Tolerability Assessment Period	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.	Up to 30 days after last dose of study drug (approximately 49 weeks)
Primary	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		14 days after the first dose of SHP674
Secondary	Percentage of Participants With Anti-Drug (SHP674) Antibody (ADA) (Part 1 and Part 2)		Predose and 25 days post dose (Part 1 and Part 2)
Secondary	Percentage of Participants With Anti-Polyethylene Glycol (PEG) Antibody (Part 1 and Part 2)		Predose and 25 days post dose (Part 1 and part 2)
Secondary	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		14 days after the first dose of SHP674
Secondary	Part 2: Percentage of Participants With Plasma Asparaginase Activity of =0.1 IU/mL or <0.1 IU/mL		Day 1 (pre-dose, 5 min, 4 hours, 24 hours post dose), Days 2, 4, 11, 14, 18, 25 post dose
Secondary	Survival Rate at 1 Year After the Start of Study Treatment	Survival rate is defined as the percentage of subjects who survived at 1 year after the start of study treatment.	1 year after the start of study treatment (from first dose up to 12 months)
Secondary	Event-free Survival Rate at 1 Year After the Start of Study Treatment	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.	1 year after the start of study treatment (from first dose up to 12 months)

External Links

•   Find Results on Servier Clinical Trial Data website