A Phase 2 interventional study of SHP674 in Acute Lymphoblastic Leukemia, sponsored by Institut de Recherches Internationales Servier. Completed at 8 sites in Japan. Open to participants aged 1 Year to 21 Years. Per ClinicalTrials.gov, last updated 2023-04-20.
Sponsored by Institut de Recherches Internationales Servier · Phase 2, Interventional, and Treatment
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 28 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Institut de Recherches Internationales Servier is the lead sponsor of 64 studies on the registry; 5 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Also known as: Pegaspargase
Part 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs During the Tolerability Assessment Period
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.
Time frame: Up to 30 days after last dose of study drug (approximately 49 weeks)
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
Percentage of Participants With Anti-Drug (SHP674) Antibody (ADA) (Part 1 and Part 2)
Time frame: Predose and 25 days post dose (Part 1 and Part 2)
Percentage of Participants With Anti-Polyethylene Glycol (PEG) Antibody (Part 1 and Part 2)
Time frame: Predose and 25 days post dose (Part 1 and part 2)
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
Survival rate is defined as the percentage of subjects who survived at 1 year after the start of study treatment.
Time frame: 1 year after the start of study treatment (from first dose up to 12 months)
Event-free Survival Rate at 1 Year After the Start of Study Treatment
Event-free survival rate is defined as percentage of subjects who did not experience any event and survived at 1 year after the start of study treatment.
Time frame: 1 year after the start of study treatment (from first dose up to 12 months)
Participants were enrolled at 8 investigative sites in Japan from 17 October 2019 to 18 January 2021. Data is reported up to primary completion date, 12 February 2021.
| Milestone | Part 1: SHP674 | Part 2: SHP674 |
|---|---|---|
| Started | 3 | 25 |
| Safety analysis set | 3 | 23 |
| - standard risk(sr)/intermediate risk (ir) | 3 | 21 |
| - hihg risk (hr) | 0 | 1 |
| - missing | 0 | 1 |
| Full analysis set | 0 | 23 |
| Immunogenicity analysis set | 3 | 22 |
| Pharmacokinetic analysis set | 3 | 23 |
| Completed | 2 | 20 |
| Not completed | 1 | 5 |
| Withdrew: Adverse event | 1 | 3 |
| Withdrew: Screen failures | 0 | 1 |
| Withdrew: Enrolled but not treated | 0 | 1 |
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.
| Participants | Part 1: SHP674 |
|---|---|
| TEAEs | 3 |
| SHP-674-Related TEAEs | 3 |
| participants | Part 2: SHP674 |
|---|---|
| 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 (85.2 to 100.0) |
| Participants | Part 1: SHP674 | Part 2: SHP674 |
|---|---|---|
| Pre-existing ADA positive | 0 | 4 |
| Seroconversion upon tretament | 0 | 2 |
| Participants | Part 1: SHP674 | Part 2: SHP674 |
|---|---|---|
| Pre-existing Anti-PEG positive | 0 | 2 |
| Seroconversion upon treatment | 0 | 0 |
| percentage of participants | Part 1: SHP674 |
|---|---|
| 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 (29.2 to 100.0) |
| percentage of participants | Part 2: SHP674 |
|---|---|
| ≥0.1 IU/mL: Day 1 (pre-dose) | 0.0 (0.0 to 14.8) |
| ≥0.1 IU/mL: Day 1 (5 mins post dose) | 100.0 (84.6 to 100.0) |
| ≥0.1 IU/mL: Day 1 (4 hours post dose) | 100.0 (85.2 to 100.0) |
| ≥0.1 IU/mL: Day 1 (24 hours post dose) | 100.0 (85.2 to 100.0) |
| ≥0.1 IU/mL: Day 2 post dose | 100.0 (85.2 to 100.0) |
| ≥0.1 IU/mL: Day 4 post dose | 100.0 (85.2 to 100.0) |
| ≥0.1 IU/mL: Day 11 post dose | 100.0 (85.2 to 100.0) |
| ≥0.1 IU/mL: Day 14 post dose | 100.0 (85.2 to 100.0) |
| ≥0.1 IU/mL: Day 18 post dose | 95.5 (77.2 to 99.9) |
| ≥0.1 IU/mL: Day 25 post dose | 50.0 (28.2 to 71.8) |
| <0.1 IU/mL : Day 1 (pre-dose) | 100.0 (85.2 to 100.0) |
| <0.1 IU/mL: Day 1 (5 mins post dose) | 0.0 (0.0 to 15.4) |
| <0.1 IU/mL: Day 1 (4 hours post dose) | 0.0 (0.0 to 14.8) |
| <0.1 IU/mL: Day 1 (24 hours post dose) | 0.0 (0.0 to 14.8) |
| <0.1 IU/mL: Day 2 post dose | 0.0 (0.0 to 14.8) |
| <0.1 IU/mL: Day 4 post dose | 0.0 (0.0 to 14.8) |
| <0.1 IU/mL: Day 11 post dose | 0.0 (0.0 to 14.8) |
| <0.1 IU/mL: Day 14 post dose | 0.0 (0.0 to 14.8) |
| <0.1 IU/mL: Day 18 post dose | 4.5 (0.1 to 22.8) |
| <0.1 IU/mL: Day 25 post dose | 50.0 (28.2 to 71.8) |
Survival rate is defined as the percentage of subjects who survived at 1 year after the start of study treatment.
| Participants | Part 1: SHP674 | Part 2: SHP674 |
|---|---|---|
| Survival Rate at 1 Year After the Start of Study Treatment | 3 | 23 |
Event-free survival rate is defined as percentage of subjects who did not experience any event and survived at 1 year after the start of study treatment.
| Participants | Part 1: SHP674 | Part 2: SHP674 |
|---|---|---|
| Event-free Survival Rate at 1 Year After the Start of Study Treatment | 3 | 23 |
Collected over Parts 1 and 2: Up to 30 days after last dose of study drug (approximatively 117 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: SHP674 | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Part 2: SHP674 | 0/23 (0%) | 10/23 (43.5%) | 23/23 (100%) |
| Event | Part 1: SHP674 | Part 2: SHP674 |
|---|---|---|
| Septic shockInfections and infestations | 1/3 | 0/23 |
| Anaphylactic transfusion reactionInjury, poisoning and procedural complications | 1/3 | 0/23 |
| Pancreatitis acuteGastrointestinal disorders | 0/3 | 1/23 |
| StomatitisGastrointestinal disorders | 0/3 | 1/23 |
| VomitingGastrointestinal disorders | 0/3 | 1/23 |
| PyrexiaGeneral disorders | 0/3 | 1/23 |
| Haemophagocytic lymphohistiocytosisImmune system disorders | 0/3 | 1/23 |
| CellulitisInfections and infestations | 0/3 | 1/23 |
| Device related infectionInfections and infestations | 0/3 | 1/23 |
| GastroenteritisInfections and infestations | 0/3 | 1/23 |
| Event | Part 1: SHP674 | Part 2: SHP674 |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 3/3 | 21/23 |
| Abdominal painGastrointestinal disorders | 3/3 | 6/23 |
| Antithrombin III decreasedInvestigations | 3/3 | 12/23 |
| Blood bilirubin increasedInvestigations | 3/3 | 9/23 |
| Blood fibrinogen decreasedInvestigations | 3/3 | 16/23 |
| Fibrin degradation products increasedInvestigations | 3/3 | 0/23 |
| Plasmin inhibitor decreasedInvestigations | 3/3 | 3/23 |
| Plasminogen decreasedInvestigations | 3/3 | 3/23 |
| Platelet count decreasedInvestigations | 3/3 | 21/23 |
| White blood cell count decreasedInvestigations | 3/3 | 21/23 |
SAF included all participants who had received at least one dose of SHP674 in Part 1 or Part 2 of the study.
| Age, Continuous(years) | Part 1: SHP674 | Part 2: SHP674 | Total |
|---|---|---|---|
| Mean | 10.2 ± 2.63 | 6.7 ± 4.79 | 7.1 ± 4.70 |
| Sex: Female, Male(Participants) | Part 1: SHP674 | Part 2: SHP674 | Total |
|---|---|---|---|
| Female | 2 | 11 | 13 |
| Male | 1 | 12 | 13 |
| Race (NIH/OMB)(Participants) | Part 1: SHP674 | Part 2: SHP674 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 23 | 26 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Part 1: SHP674 | Part 2: SHP674 | Total |
|---|---|---|---|
| Japan | 3 | 23 | 26 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in participants: * sponsored by Servier * with a first participant enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Supporting information: Study protocol, Sap, Icf, Csr
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