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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067518
Recruitment Status : Completed
First Posted : August 26, 2019
Results First Posted : June 10, 2022
Last Update Posted : August 31, 2022
Sponsor:
Collaborators:
Kyowa Kirin Co., Ltd.
ADIR, a Servier Group company
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Biological: SHP674 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The intervention study model is sequential in results section of record.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Actual Study Start Date : October 17, 2019
Actual Primary Completion Date : February 12, 2021
Actual Study Completion Date : February 4, 2022


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.

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
Other Name: Pegaspargase




Primary Outcome Measures :
  1. Part 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs During the Tolerability Assessment Period [ Time Frame: Enrollment up to 5 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.

  2. 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 ]

Secondary Outcome Measures :
  1. Incidence and Nature of TEAEs and Drug-related TEAEs [ Time Frame: Up to 1 year ]
    Data is not available as participants response is still ongoing at the time of primary analysis.

  2. Parts 1 and 2: Percentage of Participants With Anti-Drug (SHP674) Antibody (ADA) and Anti-Polyethylene Glycol (PEG) Antibody [ Time Frame: Part 1: Predose and 25 days post dose; Part 2: Predose and 25 days post dose ]
  3. 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 ]
  4. 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 ]
  5. Survival Rate at 1 Year After the Start of Study Treatment [ Time Frame: 1 year after the start of study treatment ]
    Data is not available as survival follow up of participants is still ongoing at the time of primary analysis.

  6. Event-free Survival Rate at 1 Year After the Start of Study Treatment [ Time Frame: 1 year after the start of study treatment ]
    Data is not available as survival follow up of participants is still ongoing at the time of primary analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067518


Locations
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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, Japan
Sponsors and Collaborators
Institut de Recherches Internationales Servier
Kyowa Kirin Co., Ltd.
ADIR, a Servier Group company
Investigators
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Principal Investigator: Chitose Ogawa, MD National Cancer Center Hospital, Tokyo JAPAN
  Study Documents (Full-Text)

Documents provided by Servier ( Institut de Recherches Internationales Servier ):
Study Protocol  [PDF] January 22, 2021
Statistical Analysis Plan  [PDF] April 5, 2021

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

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Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT04067518    
Other Study ID Numbers: SHP674-201/CL1-95014-001
First Posted: August 26, 2019    Key Record Dates
Results First Posted: June 10, 2022
Last Update Posted: August 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://clinicaltrials.servier.com/

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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
Keywords provided by Servier ( Institut de Recherches Internationales Servier ):
Acute Lymphoblastic Leukemia
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pegaspargase
Antineoplastic Agents