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

NCT04067518 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SHP674-201/CL1-95014-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 8

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.

Conditions

Acute Lymphoblastic Leukemia

Keywords

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (6)

• 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)

• 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)

• 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

• 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

• Survival Rate at 1 Year After the Start of Study Treatment

  1 year after the start of study treatment (from first dose up to 12 months)

Study Arms (1)

SHP674

EXPERIMENTAL

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.

Biological: SHP674

Interventions

SHP674 BIOLOGICAL

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

Also known as: Pegaspargase

SHP674

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Recherches Internationales Servier: lead
• Kyowa Kirin Co., Ltd.: collaborator
• ADIR, a Servier Group company: collaborator

Study Sites (8)

Kagoshima University Hospital Department of Pediatrics

Kagoshima, Japan

Location

Kobe Children's Hospital Department of Hematology/Oncology

Kobe, Japan

Location

Nagoya Medical Center Department of Pediatrics

Nagoya, Japan

Location

Niigata Cancer Center Hospital

Niigata, Japan

Location

Saitama Children's Medical Center Department of Hematology/Oncology

Saitama, Japan

Location

Sapporo Hokuyu Hospital Department of Pediatrics and Adolescent Medicine

Sapporo, Japan

Location

National Cancer Center Hospital Department of Pediatric Oncology

Tokyo, Japan

Location

St. Luke's International Hospital Department of Pediatrics

Tokyo, Japan

Location

Related Links

• Find Results on Servier Clinical Trial Data website

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

pegaspargase

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Clinical Studies Department
• Organization: Institut de Recherches Internationales Servier

scientificinformation@servier.com

+33 1 55 72 43 66

Study Officials

• Chitose Ogawa, MD

  National Cancer Center Hospital, Tokyo JAPAN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention study model is sequential in results section of record.

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 26, 2019
• Study Start: October 17, 2019
• Primary Completion: February 12, 2021
• Study Completion: February 4, 2022
• Last Updated: April 20, 2023
• Results First Posted: June 10, 2022

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
• Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

Locations

JP (8)