Phase 2
Completed N=28
A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov NCT04067518 ↗Enrolled (actual)
28
Serious AEs
42.3%
Results posted
Jun 2022
Primary outcomePrimary: Part 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs During the Tolerability Assessment Period — 3; 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs During the Tolerability Assessment Period |
3; 3 | — |
| PRIMARY 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 |
100.0 | — |
| SECONDARY Percentage of Participants With Anti-Drug (SHP674) Antibody (ADA) (Part 1 and Part 2) |
0; 4; 0; 2 | — |
| SECONDARY Percentage of Participants With Anti-Polyethylene Glycol (PEG) Antibody (Part 1 and Part 2) |
0; 2; 0; 0 | — |
| SECONDARY 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 |
100.0 | — |
| SECONDARY Part 2: Percentage of Participants With Plasma Asparaginase Activity of ≥0.1 IU/mL or <0.1 IU/mL |
0.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Survival Rate at 1 Year After the Start of Study Treatment |
3; 23 | — |
| SECONDARY Event-free Survival Rate at 1 Year After the Start of Study Treatment |
3; 23 | — |
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
Data sourced from ClinicalTrials.gov (NCT04067518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.