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.
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
Drug | Synonyms | Arms |
---|
Pegaspargase | | Pegaspargase 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
Name | Type | Description | Interventions |
---|
Pegaspargase arm | Experimental | | |
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: | Active, not recruiting |
Lead Sponsor: | Institut de Recherches Internationales Servier |
Trial Keywords
- Acute Lymphoblastic Leukemia
Last Updated
May 18, 2021