Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Pharmaceutical Solutions

All Drugs and Chemicals

Antineoplastic Agents

Pegaspargase

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.

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

SHP674

Chitose Ogawa, MD

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.

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

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

A Phase 2 Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia

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.

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.

Survival rate is defined as the percentage of subjects who survived 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.

Kyowa Kirin Co., Ltd.

ADIR, a Servier Group company

Institut de Recherches Internationales Servier

SAF included all participants who had received at least one dose of SHP674 in Part 1 or Part 2 of the study. As planned and pre-specified in protocol, the safety data was analyzed for Part 1 and Part 2 of study.

Participants with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m\^2 (if BSA ≥0.6 m\^2) or 82.5 IU/kg (if BSA \<0.6 m\^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4) in the 5-week tolerability assessment period, Day 2 of re-induction therapy (conducted twice) in the 36-week treatment period.

Part 1: SHP674

Participants with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m\^2 (if BSA ≥0.6 m\^2) or 82.5 IU/kg (if BSA \<0.6 m\^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4), Day 2 of re-induction therapy (conducted twice) in the 41-week treatment period and who were stratified into the HR group received total 8 doses of SHP674, 2500 IU/m\^2 (if BSA ≥0.6 m\^2) or 82.5 IU/kg (if BSA \<0.6 m\^2) IV on Day 12 of Remission induction therapy (IA4), Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.

Part 2: SHP674

Total

Age, Continuous

Sex: Female, Male

Definition of racial groups according to NIH (National Institutes of Health) and OMB (Office of Management and Budget)

Race (NIH/OMB)

Japan

Region of Enrollment

SAF included all participants who had received at least one dose of SHP674 in Part 1 or Part 2 of the study.

Clinical Studies Department

TEAEs

SHP-674-Related TEAEs

SAF (Safety Analysis Set) included all participants who had received at least one dose of SHP674 in Part 1 or Part 2 of the study. As pre-specified in the protocol, this outcome measure is analyzed only for Part 1.

Part 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs During the Tolerability Assessment Period

FAS (Full Analysis Set) included all participants who were enrolled and received SHP674 in Part 2 of the study.

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

Pre-existing ADA positive

Seroconversion upon tretament

Immunogenicity analysis set (IMAS) included all participants who had received at least one dose of SHP674 in Part 1 or Part 2 of the study and had at least one evaluable post-dose sample. If the pre-dose sample was missing it was considered negative.

Percentage of Participants With Anti-Drug (SHP674) Antibody (ADA) (Part 1 and Part 2)

Pre-existing Anti-PEG positive

Seroconversion upon treatment

Participants with ALL who were stratified into the standard risk (SR) or intermediate risk (IR) groups received total 3 doses of SHP674, 2500 international units per square meter (IU/m\^2) (if body surface area \[BSA\] ≥0.6 m\^2) or 82.5 international units per kilogram (IU/kg) (if BSA \<0.6 m\^2) intravenously (IV) on Day 12 of Remission induction therapy (SR: IA2/IR: IA4) in the 5-week tolerability assessment period, Day 2 of re-induction therapy (conducted twice) in the 36-week treatment period.

Participants with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m\^2 (if BSA ≥0.6 m\^2) or 82.5 IU/kg (if BSA \<0.6 m\^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4), Day 2 of re-induction therapy (conducted twice) in the 41-week treatment period.

Participants with ALL who were stratified into the HR group received total 8 doses of SHP674, 2500 IU/m\^2 (if BSA ≥0.6 m\^2) or 82.5 IU/kg (if BSA \<0.6 m\^2) IV on Day 12 of Remission induction therapy (IA4), Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.

Percentage of Participants With Anti-Polyethylene Glycol (PEG) Antibody (Part 1 and Part 2)

Participants with Acute Lymphoblastic Leukemia (ALL) who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m\^2 (if BSA ≥0.6 m\^2) or 82.5 IU/kg (if BSA \<0.6 m\^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4) in the 5-week tolerability assessment period, Day 2 of re-induction therapy (conducted twice) in the 36-week treatment period.

SAF included all participants who had received at least one dose of SHP674 in Part 1 or Part 2 of the study. As pre-specified in the protocol, this outcome measure is analyzed only for Part 1.

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

≥0.1 IU/mL: Day 1 (pre-dose)

≥0.1 IU/mL: Day 1 (5 mins post dose)

≥0.1 IU/mL: Day 1 (4 hours post dose)

≥0.1 IU/mL: Day 1 (24 hours post dose)

≥0.1 IU/mL: Day 2 post dose

≥0.1 IU/mL: Day 4 post dose

≥0.1 IU/mL: Day 11 post dose

≥0.1 IU/mL: Day 14 post dose

≥0.1 IU/mL: Day 18 post dose

≥0.1 IU/mL: Day 25 post dose

<0.1 IU/mL : Day 1 (pre-dose)

<0.1 IU/mL: Day 1 (5 mins post dose)

<0.1 IU/mL: Day 1 (4 hours post dose)

<0.1 IU/mL: Day 1 (24 hours post dose)

<0.1 IU/mL: Day 2 post dose

<0.1 IU/mL: Day 4 post dose

<0.1 IU/mL: Day 11 post dose

<0.1 IU/mL: Day 14 post dose

<0.1 IU/mL: Day 18 post dose

<0.1 IU/mL: Day 25 post dose

FAS included all participants who were enrolled and received SHP674 in Part 2 of the study. Number analyzed indicates the number of participants analyzed at the specified timepoint.

Part 2: Percentage of Participants With Plasma Asparaginase Activity of ≥0.1 IU/mL or <0.1 IU/mL

The analysis was performed on the safety set analysis, defined as the set of all subjects who had received at least one dose of SHP674 in Part 1 or Part 2 of the study.

Spots Global Cancer Trial Database for A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia

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Study Description

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