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

NCT04067518

Description:

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.

Related Conditions:
  • B-Cell Acute Lymphoblastic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
  • Official Title: A Phase 2 Clinical Study of Pegaspargase in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia

Clinical Trial IDs

  • ORG STUDY ID: SHP674-201/CL1-95014-001
  • NCT ID: NCT04067518

Conditions

  • Acute Lymphoblastic Leukemia

Interventions

DrugSynonymsArms
PegaspargasePegaspargase arm

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Pegaspargase armExperimental
  • Pegaspargase

Eligibility 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
      
Maximum Eligible Age:21 Years
Minimum Eligible Age:1 Year
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence and nature of treatment-emergent adverse events (TEAEs) and drug-related TEAEs
Time Frame:Up to 1 year
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Survival rate at 1 year after the start of study treatment
Time Frame:1 year after the start of study treatment
Safety Issue:
Description:
Measure:Event-free survival rate at 1 year after the start of study treatment
Time Frame:1 year after the start of study treatment
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Institut de Recherches Internationales Servier

Trial Keywords

  • Acute Lymphoblastic Leukemia

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