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A Clinical Study of SHP674 in Patients 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067518
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : February 19, 2020
Sponsor:
Collaborators:
Kyowa Kirin Co., Ltd.
ADIR, a Servier Group company
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Study Description
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Brief Summary:
The objectives of the study are to 1) assess the safety and tolerability of a single dose of Pegaspargase in Japanese patients (dose confirmation) in the tolerability assessment period; and 2) to assess the safety, pharmacokinetics and efficacy of Pegaspargase in the treatment of newly diagnosed untreated acute lymphoblastic leukemia in Japanese patients.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Clinical Study of Pegaspargase in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pegaspargase arm Biological: Pegaspargase
Pegaspargase : powder for solution for injection, IV (administered by 1 to 2 hours of drip infusion), dose determination : if BSA ≥0.6 m2: 2500 IU/m2 every 14 days if BSA <0.6 m2: 82.5 IU/kg every 14 days


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients who have a plasma asparaginase activity of ≥0.1 IU/mL 14 days (336 hours) after the first dose of Pegaspargase [ Time Frame: 14 days after the first dose of Pegaspargase in Remission Induction phase ]

Secondary Outcome Measures :
  1. Incidence and nature of treatment-emergent adverse events (TEAEs) and drug-related TEAEs [ Time Frame: Up to 1 year ]
  2. Plasma Asparaginase Activity with therapeutic threshold of 0.1 IU/mL Asparaginase measured by coupled enzymatic activity assay [ Time Frame: Prior to, and including 11, 14, and 25 days after Pegaspargase administration ]
  3. Survival rate at 1 year after the start of study treatment [ Time Frame: 1 year after the start of study treatment ]
  4. Event-free survival rate at 1 year after the start of study treatment [ Time Frame: 1 year after the start of study treatment ]

Eligibility Criteria
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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
Contacts and Locations
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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


Contacts
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Contact: Institut de Recherches Internationales Servier Clinical Studies Department +33 1 55 72 43 66 clinicaltrials@servier.com

Locations
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Japan
Kagoshima University Hospital Department of Pediatrics Not yet recruiting
Kagoshima, Japan
Kobe Children's Hospital Department of Hematology/Oncology Not yet recruiting
Kobe, Japan
Nagoya Medical Center Department of Pediatrics Not yet recruiting
Nagoya, Japan
Saitama Children's Medical Center Department of Hematology/Oncology Recruiting
Saitama, Japan
Sapporo Hokuyu Hospital Department of Pediatrics and Adolescent Medicine Not yet recruiting
Sapporo, Japan
National Cancer Center Hospital Department of Pediatric Oncology Not yet recruiting
Tokyo, Japan
St. Luke's International Hospital Department of Pediatrics Not yet recruiting
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
More Information
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Additional Information:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Study Protocol  This link exits the ClinicalTrials.gov site
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Informed Consent Form  This link exits the ClinicalTrials.gov site
Clinical Study Report  This link exits the ClinicalTrials.gov site
study-level clinical trial data  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
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask for all interventional clinical studies:

  • submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
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: http://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