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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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:
  • Pegaspargase

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
14 days after the first dose of SHP674
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)
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)

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
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
Time Frame: Day 1 (pre-dose, 5 min, 4 hours, 24 hours post dose), Days 2, 4, 11, 14, 18, 25 post dose
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
Time Frame: 1 year after the start of study treatment (from first dose up to 12 months)
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)
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)
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)
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)
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)
Time Frame: Predose and 25 days post dose (Part 1 and part 2)
Predose and 25 days post dose (Part 1 and part 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chitose Ogawa, MD, National Cancer Center Hospital, Tokyo JAPAN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2019

Primary Completion (Actual)

February 12, 2021

Study Completion (Actual)

February 4, 2022

Study Registration Dates

First Submitted

August 13, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (Actual)

August 26, 2019

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

After Marketing Authorisation in EEA or US if the study is used for the approval.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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.

Clinical Trials on Acute Lymphoblastic Leukemia

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