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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-17

Study Completion Date

2022-02-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The intervention study model is sequential in results section of record.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SHP674

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Other Intervention Names

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Pegaspargase

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No