A Clinical Study of SHP674 (Pegaspargase) in Participants 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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04067518 |
Recruitment Status :
Completed
First Posted : August 26, 2019
Results First Posted : June 10, 2022
Last Update Posted : August 31, 2022
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Lymphoblastic Leukemia | Biological: SHP674 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | The intervention study model is sequential in results section of record. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia |
Actual Study Start Date : | October 17, 2019 |
Actual Primary Completion Date : | February 12, 2021 |
Actual Study Completion Date : | February 4, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: 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. |
Biological: 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
Other Name: Pegaspargase |
- Part 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs During the Tolerability Assessment Period [ Time Frame: Enrollment up to 5 weeks ]An adverse event (AE) is defined as any untoward medical occurrence in a participant after signing informed consent. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease, whether or not it is related to the investigational product. TEAE is defined as any untoward medical occurrence in a participant who received an investigational product which occurs during the period from Day 1 of the pre-treatment phase to 30 (+7) days after the last dose of investigational product, or until the start of a new therapy, whichever occurs first. A related adverse event signifies that there is a reasonable causal relationship between study treatment and an AE.
- 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 [ Time Frame: 14 days after the first dose of SHP674 ]
- Incidence and Nature of TEAEs and Drug-related TEAEs [ Time Frame: Up to 1 year ]Data is not available as participants response is still ongoing at the time of primary analysis.
- Parts 1 and 2: Percentage of Participants With Anti-Drug (SHP674) Antibody (ADA) and Anti-Polyethylene Glycol (PEG) Antibody [ Time Frame: Part 1: Predose and 25 days post dose; Part 2: Predose and 25 days post dose ]
- 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 [ Time Frame: 14 days after the first dose of SHP674 ]
- Part 2: Percentage of Participants With Plasma Asparaginase Activity of ≥0.1 IU/mL or <0.1 IU/mL [ Time Frame: Day 1 (pre-dose, 5 min, 4 hours, 24 hours post dose), Days 2, 4, 11, 14, 18, 25 post dose ]
- Survival Rate at 1 Year After the Start of Study Treatment [ Time Frame: 1 year after the start of study treatment ]Data is not available as survival follow up of participants is still ongoing at the time of primary analysis.
- Event-free Survival Rate at 1 Year After the Start of Study Treatment [ Time Frame: 1 year after the start of study treatment ]Data is not available as survival follow up of participants is still ongoing at the time of primary analysis.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 1 Year to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Japan | |
Kagoshima University Hospital Department of Pediatrics | |
Kagoshima, Japan | |
Kobe Children's Hospital Department of Hematology/Oncology | |
Kobe, Japan | |
Nagoya Medical Center Department of Pediatrics | |
Nagoya, Japan | |
Niigata Cancer Center Hospital | |
Niigata, Japan | |
Saitama Children's Medical Center Department of Hematology/Oncology | |
Saitama, Japan | |
Sapporo Hokuyu Hospital Department of Pediatrics and Adolescent Medicine | |
Sapporo, Japan | |
National Cancer Center Hospital Department of Pediatric Oncology | |
Tokyo, Japan | |
St. Luke's International Hospital Department of Pediatrics | |
Tokyo, Japan |
Principal Investigator: | Chitose Ogawa, MD | National Cancer Center Hospital, Tokyo JAPAN |
Documents provided by Servier ( Institut de Recherches Internationales Servier ):
Study Data/Documents: Individual Participant Data Set

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 |
Results First Posted: | June 10, 2022 |
Last Update Posted: | August 31, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified scientific and medical researchers can request access to anonymized participant-level and study-level clinical trial data. Access can be requested for all interventional clinical studies:
In addition, access can be requested for all interventional clinical studies in participants:
|
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: | https://clinicaltrials.servier.com/ |
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 |
Acute Lymphoblastic Leukemia |
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 |