Acute Lymphoblastic LeukemiaPhase 2/3NCT04817761

SPARK-ALL: Calaspargase Pegol in Adults With ALL

A Phase 2/3 study testing Calaspargase pegol (S95015) in people with Acute Lymphoblastic Leukemia, run by Institut de Recherches Internationales Servier at 21 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this phase 2/3 study is to confirm the recommended doses and to evaluate the safety and pharmacodynamics of Calaspargase pegol for the treatment of adult patients with Philadelphia-negative Acute Lymphoblastic Leukemia. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Acute Lymphoblastic Leukemia
What is being tested?: Calaspargase pegol (S95015)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 21 sitesUnited States
Study dates: 7 Jul 2021to 6 Apr 2025
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged ≥22 with newly-diagnosed and cytologically confirmed and documented Philadelphia-negative B-cell or T-cell ALL by World Health Organization (WHO) classification (2016).
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2.
No prior therapy for ALL such as chemotherapy and radiation therapy before signing the informed consent except for limited treatment (≤7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine.

Who cannot join

Patients with Philadelphia chromosome positive ALL, Burkitt's leukemia, mixed lineage/mixed phenotype acute leukemia, and acute undifferentiated leukemia per WHO classification (2016).
Patients with Down syndrome.
Patients with Hepatitis B (positive for HBs antigen), and Hepatitis C (HCV antibody) at inclusion
Participants known to be HIV-positive.
Known history of non-gallstone-related pancreatitis.
Known severe hepatic impairment (bilirubin >3 x upper limit of normal [ULN]; transaminases >5 times ULN (unless suspected leukemic involvement of the liver).
Pre-existing history of hepatic veno-occlusive disease (VOD).
BMI > 35 kg/m2 (This criterion was introduced as an amendment for Part 2)

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
University of Chicago Medicine
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Duke University
Durham, North Carolina, 27705
Northwell Health Cancer Institute
Lake Success, New York, 11042
Univeristy of California
Los Angeles, California, 90095
Baptist Clinical Research Institute
Memphis, Tennessee, 38120
University of Miami Health System - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
West Virginia University Cancer Institute
Morgantown, West Virginia, 26506
NYU Langone/Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of California Irvine Health (UCI Health)
Orange, California, 92868
Jefferson Health
Philadelphia, Pennsylvania, 19107
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Intermountain Healthcare (IHC)
Salt Lake City, Utah, 84143
HonorHealth Cancer Transplant Institute
Scottsdale, Arizona, 85258
University of Washington/Seattle Cancer Care Alliance/Fred Hutch
Seattle, Washington, 98109
University of Kansas Cancer Center - Richard and Annette Bloch Cancer Care Pavilion
Westwood, Kansas, 66205
Dana Farber Cancer Institute
Weymouth, Massachusetts, 02190

Other trials in United States

About this study

Official title: SPARK-ALL: A Multi-center, Open-label, Single-arm Phase 2/3 Trial Evaluating the Safety and Pharmacokinetics of Calaspargase Pegol for Treatment of Adults Aged 22 To >65 Years With Newly-diagnosed Philadelphia-negative ALL.

Read the detailed description

The study will be conducted in 2 parts. Part 1 is a dose confirmation run-in period. Part 2 will enroll the remaining participants at the dose as confirmed or recommended in Part 1.

Conditions: Acute Lymphoblastic Leukemia
Being tested: Calaspargase pegol (S95015)
Keywords: Acute Lymphoblastic Leukemia, ALL, Ph-negative B-cell and T cell ALL, Philadelphia-negative ALL, Calaspargase Pegol, Asparlas, Adult, Acute Lymphocytic Leukemia, Newly diagnosed ALL, Untreated ALL
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Calaspargase pegol (S95015)Drug
Part 1: S95015 will be administered at dose of 2000 U/m2, 1500 U/m2 or 1000 U/m2 (dose level based on age and BMI) via a 2-hour intravenous infusion at Day 4 (or 5, or 6) of the induction phase, Days 15 and 43 of the consolidation phase, Day 22 of the interim maintenance phase and Days 4 (or 5, or 6) and 43 of the delayed intensification phase. S95015 starting doses for age and BMI groups will be confirmed.
Patients will receive premedication prior to calaspargase pegol administration (acetaminophen, histamine-1 blocker, and corticosteroids to prevent hypersensitivity reaction) and other backbone chemotherapy agents based on the CALGB 10403 protocol treatment regimen.
Part 2: Patients aged 22 to 39 years + BMI ≤ 35 kg/m2 will be treated with S95015 1750 U/m2.
Patients aged 40 to < 55 years + BMI ≤ 35 kg/m2 will be treated with S95015 1500 U/m2, unchanged from Part 1. Patients 55 years or older or those with a BMI greater than 35 kg/m2 will no longer be enrolled into Part 2.

Study groups in NCT04817761
Study group	Role	What they receive
Calaspargase pegol (S95015)	Experimental	Not described Receives: Drug: Calaspargase pegol (S95015)

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events (AEs)
Including Treatment-emergent adverse events (TEAEs), adverse events of special interests (AESI); and serious adverse events (SAEs). AEs recorded and evaluated throughout the study in accordance with NCI CTCAE criteria 5.0.
Measured: Through study completion, approximately 3.5 years
Plasma Asparaginase Activity (PAA) Level (Part 1 and Part 2)
Assessment of PAA in Part 1 is based on population modeling analysis.
Measured: 7 days, 14 days, 21 days after last administration in the Remission Induction phase (Day 0-35 post baseline) and the Remission Consolidation phase (Day 36-91 post baseline)
Nadir Plasma Asparaginase Activity (NPAA) (Part 2)
Participants with NPAA level ≥0.1 U/mL 21 days after the Remission Consolidation Phase Day 43 dose.
Measured: Day 64 (Remission Consolidation Phase Day 36-91 post baseline).

Secondary outcomes (13)

Number of Participants With Plasma Asparaginase Activity (PAA) Level ≥0.1 U/mL at Any Time During Remission Induction Phase and Post- Remission Induction Phase, Respectively (Part 1 and Part 2)
Pharmacodynamics criterion.
Measured: Days 4-5-6&11-18-25 (Induction, Day 0-35 PB (post baseline)); Days 15-16-43-44&22-29-36-50-57-64 (Consolidation, Day 36-91 PB); Days 22-23&29-36-43 (Maintenance, Day 92-147 PB); Days 4-5,43-44 & 11-18-25-50-57-64 (Delayed Intensification, Day 148-203 PB)
Plasma Asparaginase Activity (PAA) Level ≥0.025 U/mL at Predefined Time Points During Remission Induction Phase and Post- Remission Induction Phase, Respectively (Part 1 and Part 2)
Pharmacodynamics criterion.
Measured: 7 days, 14 days, and 21 days after last administration in the Remission Induction phase (Day 0-35 post baseline) and pre-dose, 7 days, 14 days, and 21 days after last administration in the Remission Consolidation phase (Day 36-91 post baseline)
Plasma Asparaginase Activity (PAA) Level ≥0.1 U/mL at Predefined Time Points During Remission Induction Phase and Post- Remission Induction Phase, Respectively (Part 1 and Part 2)
Pharmacodynamics criterion.
Measured: 7 days, 14 days, and 21 days after last administration in the Remission Induction phase (Day 0-35 post baseline) and pre-dose, 7 days, 14 days, and 21 days after last administration in the Remission Consolidation phase (Day 36-91 post baseline)
Plasma Asparaginase Activity (PAA) Level ≥0.2 U/mL at Predefined Time Points During Remission Induction Phase and Post- Remission Induction Phase, Respectively (Part 1 and Part 2)
Pharmacodynamics criterion.
Measured: 7 days, 14 days, and 21 days after last administration in the Remission Induction phase (Day 0-35 post baseline) and pre-dose, 7 days, 14 days, and 21 days after last administration in the Remission Consolidation phase (Day 36-91 post baseline)
Plasma Asparaginase Activity (PAA) Level ≥0.4 U/mL at Predefined Time Points During Remission Induction Phase and Post- Remission Induction Phase, Respectively (Part 1 and Part 2)
Pharmacodynamics criterion.
Measured: 7 days, 14 days, and 21 days after last administration in the Remission Induction phase (Day 0-35 post baseline) and pre-dose, 7 days, 14 days, and 21 days after last administration in the Remission Consolidation phase (Day 36-91 post baseline)
PAA-derived Maximum Concentration (Cmax) After the Remission Induction Phase Day 4 Dose (Part 1 and 2).
PAA-derived Cmax are based on population modeling analysis.
Measured: From days 4-25 (Remission Induction, Day 0-35 post baseline)
PAA-derived Area Under the PAA-Time Curve From Time 0 to Day 35 (AUC 0-35) After the Remission Induction Phase Day 4 Dose (Part 1 and 2).
PAA-derived AUC 0-35 are based on population modeling analysis.
Measured: From Days 0-35 (Remission Induction, Day 0-35 post baseline)
Minimal Residual Disease (MRD) at End of Remission Induction (Part 1 and 2)
Efficacy criterion. A positive result indicates that there is some disease still present. A negative result indicates that there is no disease present.
Measured: End of remission induction phase (Day 0-35 post baseline) (Day 29).
Participants Who Achieved Complete Remission (CR) (Part 1 and 2)
Morphologic complete remission rate (CR), morphologic complete remission rate with incomplete blood count recovery (CRi).
Measured: Day 29 remission induction phase (Day 0-35 post baseline)
EFS (Event-free Survival) (Part 1 and 2)
Probability estimates for EFS until 1 year, 2 years, and 3 years
Measured: Through study completion an average of 3.5 years
DFS (Disease-free Survival) (Part 1 and 2)
Probability estimates for DFS until 1 year, 2 years, and 3 years
Measured: Through study completion an average of 3.5 years
OS (Overall Survival) (Part 1 and 2)
Probability estimates for OS until 1 year, 2 years, and 3 years
Measured: Through study completion an average of 3.5 years
Anti-drug (Calaspargase Pegol) Antibody (ADA) Development (Part 1 and 2)
Immunogenicity criterion.
Measured: Through 365 (±7) days after the first dose or 30 days after the last dose if the participant discontinued

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jul 20216 Apr 2025

First posted26 Mar 2021
Study start7 Jul 2021
Primary completion6 Apr 2025
Study completion6 Apr 2025

Why it stopped: Sponsor decision.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04817761
Sponsor's protocol ID: CL2-95015-001
Status last verified: Oct 2026
First submitted: 15 Mar 2021
Last updated: 29 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified scientific and medical researchers can request access to anonymized patient-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 patients: * sponsored by Servier * with a first patient 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.

Publications

Stock W, Park JH, Emadi A, Abdul-Hay M, Cassaday RD, Pullarkat VA, Webster J, Pandya SS, Mogul MJ, Shvenke Y, Zhu JJ, Tessier A, DeAngelo DJ. Safety and Pharmacokinetics of Calaspargase Pegol in Adults with Newly Diagnosed Philadelphia-Negative ALL: A Phase 2/3 Study. Blood. 2021 Nov 23;138(Supplement 1):4406. doi: https://doi.org/10.1182/blood-2021-149463
Aldoss I, Ali A, Cassaday RD, Curran EK, Luskin MR, Maese LD, Orgel E, Douer D. Optimizing Asparaginase Treatment for Adolescent and Young Adult (AYA) Patients With Acute Lymphoblastic Leukemia: US Consensus Panel Recommendations. Am J Hematol. 2026 Jan;101(1):41-55. doi: 10.1002/ajh.70103. Epub 2025 Oct 11.
PubMed 41074700

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SPARK-ALL: A Multi-center, Open-label, Single-arm Phase 2/3 Trial Evaluating the Safety and Pharmacokinetics of Calaspargase Pegol for Treatment of Adults Aged 22 To >65 Years With Newly-diagnosed Philadelphia-negative ALL.
ClinicalTrials.gov ID: NCT04817761
Acronym / sponsor ID: CL2-95015-001
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic Leukemia, ALL, Ph-negative B-cell and T cell ALL, Philadelphia-negative ALL, Calaspargase Pegol, Asparlas, Adult, Acute Lymphocytic Leukemia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision.
Enrolment: 42 participants (actual)
Lead sponsor: Institut de Recherches Internationales ServierUniversity, hospital or other
Study start: 7 Jul 2021 (actual)
Primary completion: 6 Apr 2025 (actual)
Study completion: 6 Apr 2025 (actual)
First posted: 26 Mar 2021 (actual)
Results: Posted 29 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will be conducted in 2 parts. Part 1 is a dose confirmation run-in period. Part 2 will enroll the remaining participants at the dose as confirmed or recommended in Part 1.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Calaspargase pegol (S95015)	Experimental	Drug: Calaspargase pegol (S95015)

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Aged ≥22 with newly-diagnosed and cytologically confirmed and documented Philadelphia-negative B-cell or T-cell ALL by World Health Organization (WHO) classification (2016).
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2.
No prior therapy for ALL such as chemotherapy and radiation therapy before signing the informed consent except for limited treatment (≤7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine.

Key exclusion criteria (8 listed)

Patients with Philadelphia chromosome positive ALL, Burkitt's leukemia, mixed lineage/mixed phenotype acute leukemia, and acute undifferentiated leukemia per WHO classification (2016).
Patients with Down syndrome.
Patients with Hepatitis B (positive for HBs antigen), and Hepatitis C (HCV antibody) at inclusion
Participants known to be HIV-positive.
Known history of non-gallstone-related pancreatitis.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Calaspargase pegol (S95015)Part 1: S95015 will be administered at dose of 2000 U/m2, 1500 U/m2 or 1000 U/m2 (dose level based on age and BMI) via a 2-hour intravenous infusion at Day 4 (or 5, or 6) of the induction phase, Days 15 and 43 of the consolidation phase, Day 22 of the interim maintenance phase and Days 4 (or 5, or 6) and 43 of the delayed intensification phase. S95015 starting doses for age and BMI groups will be confirmed. Patients will receive premedication prior to calaspargase pegol administration (acetaminophen, histamine-1 blocker, and corticosteroids to prevent hypersensitivity reaction) and other backbone chemotherapy agents based on the CALGB 10403 protocol treatment regimen. Part 2: Patients aged 22 to 39 years + BMI ≤ 35 kg/m2 will be treated with S95015 1750 U/m2. Patients aged 40 to < 55 years + BMI ≤ 35 kg/m2 will be treated with S95015 1500 U/m2, unchanged from Part 1. Patients 55 years or older or those with a BMI greater than 35 kg/m2 will no longer be enrolled into Part 2.	Drug	Calaspargase pegol (S95015)

Primary outcome

Adverse Events (AEs)
Time frame: Through study completion, approximately 3.5 years
Including Treatment-emergent adverse events (TEAEs), adverse events of special interests (AESI); and serious adverse events (SAEs). AEs recorded and evaluated throughout the study in accordance with NCI CTCAE criteria 5.0.
Plasma Asparaginase Activity (PAA) Level (Part 1 and Part 2)
Time frame: 7 days, 14 days, 21 days after last administration in the Remission Induction phase (Day 0-35 post baseline) and the Remission Consolidation phase (Day 36-91 post baseline)
Assessment of PAA in Part 1 is based on population modeling analysis.
Nadir Plasma Asparaginase Activity (NPAA) (Part 2)
Time frame: Day 64 (Remission Consolidation Phase Day 36-91 post baseline).
Participants with NPAA level ≥0.1 U/mL 21 days after the Remission Consolidation Phase Day 43 dose.

13 secondary outcomes

Number of Participants With Plasma Asparaginase Activity (PAA) Level ≥0.1 U/mL at Any Time During Remission Induction Phase and Post- Remission Induction Phase, Respectively (Part 1 and Part 2)
Time frame: Days 4-5-6&11-18-25 (Induction, Day 0-35 PB (post baseline)); Days 15-16-43-44&22-29-36-50-57-64 (Consolidation, Day 36-91 PB); Days 22-23&29-36-43 (Maintenance, Day 92-147 PB); Days 4-5,43-44 & 11-18-25-50-57-64 (Delayed Intensification, Day 148-203 PB)
Plasma Asparaginase Activity (PAA) Level ≥0.025 U/mL at Predefined Time Points During Remission Induction Phase and Post- Remission Induction Phase, Respectively (Part 1 and Part 2)
Time frame: 7 days, 14 days, and 21 days after last administration in the Remission Induction phase (Day 0-35 post baseline) and pre-dose, 7 days, 14 days, and 21 days after last administration in the Remission Consolidation phase (Day 36-91 post baseline)
Plasma Asparaginase Activity (PAA) Level ≥0.1 U/mL at Predefined Time Points During Remission Induction Phase and Post- Remission Induction Phase, Respectively (Part 1 and Part 2)
Time frame: 7 days, 14 days, and 21 days after last administration in the Remission Induction phase (Day 0-35 post baseline) and pre-dose, 7 days, 14 days, and 21 days after last administration in the Remission Consolidation phase (Day 36-91 post baseline)
Plasma Asparaginase Activity (PAA) Level ≥0.2 U/mL at Predefined Time Points During Remission Induction Phase and Post- Remission Induction Phase, Respectively (Part 1 and Part 2)
Time frame: 7 days, 14 days, and 21 days after last administration in the Remission Induction phase (Day 0-35 post baseline) and pre-dose, 7 days, 14 days, and 21 days after last administration in the Remission Consolidation phase (Day 36-91 post baseline)
Plasma Asparaginase Activity (PAA) Level ≥0.4 U/mL at Predefined Time Points During Remission Induction Phase and Post- Remission Induction Phase, Respectively (Part 1 and Part 2)
Time frame: 7 days, 14 days, and 21 days after last administration in the Remission Induction phase (Day 0-35 post baseline) and pre-dose, 7 days, 14 days, and 21 days after last administration in the Remission Consolidation phase (Day 36-91 post baseline)
PAA-derived Maximum Concentration (Cmax) After the Remission Induction Phase Day 4 Dose (Part 1 and 2).
Time frame: From days 4-25 (Remission Induction, Day 0-35 post baseline)
PAA-derived Area Under the PAA-Time Curve From Time 0 to Day 35 (AUC 0-35) After the Remission Induction Phase Day 4 Dose (Part 1 and 2).
Time frame: From Days 0-35 (Remission Induction, Day 0-35 post baseline)
Minimal Residual Disease (MRD) at End of Remission Induction (Part 1 and 2)
Time frame: End of remission induction phase (Day 0-35 post baseline) (Day 29).
Participants Who Achieved Complete Remission (CR) (Part 1 and 2)
Time frame: Day 29 remission induction phase (Day 0-35 post baseline)
EFS (Event-free Survival) (Part 1 and 2)
Time frame: Through study completion an average of 3.5 years
DFS (Disease-free Survival) (Part 1 and 2)
Time frame: Through study completion an average of 3.5 years
OS (Overall Survival) (Part 1 and 2)
Time frame: Through study completion an average of 3.5 years
Anti-drug (Calaspargase Pegol) Antibody (ADA) Development (Part 1 and 2)
Time frame: Through 365 (±7) days after the first dose or 30 days after the last dose if the participant discontinued

Results and safety

Results posted to the registry on 29 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 2: Calaspargase Pegol (S95015) 1750 U/m2	9	9
Part 1 and Part 2: Calaspargase Pegol (S95015) 1500 U/m2	11	10
Part 1: Calaspargase Pegol (S95015) 2000 U/m2	6	5
Part 1: Calaspargase Pegol (S95015) 1000 U/m2 (≥ 55 Years)	8	5
Part 1: Calaspargase Pegol (S95015) 1000 U/m2 (<55 Years)	8	5

Primary outcome: Adverse Events (AEs)

Time frame: Through study completion, approximately 3.5 years. Count of participants. Unit: Participants

Measure	Part 1: Calaspargase Pegol (S95015) 2000 U/m2 n = 6	Part 1: Calaspargase Pegol (S95015) 1000 U/m2 (≥ 55 Years) n = 8	Part 1: Calaspargase Pegol (S95015) 1000 U/m2 (<55 Years) n = 8	Part 2: Calaspargase Pegol (S95015) 1750 U/m2 n = 9	Part 1 and Part 2: Calaspargase Pegol (S95015) 1500 U/m2 n = 11
TEAEs	6	8	8	9	11
AESIs	4	6	6	7	6
SAEs	2	6	5	8	7

Primary outcome: Plasma Asparaginase Activity (PAA) Level (Part 1 and Part 2)

Time frame: 7 days, 14 days, 21 days after last administration in the Remission Induction phase (Day 0-35 post baseline) and the Remission Consolidation phase (Day 36-91 post baseline). Mean (Standard Deviation). Unit: U/mL

Measure	Part 2: Calaspargase Pegol (S95015) 1750 U/m2 n = 9	Part 1: Calaspargase Pegol (S95015) 2000 U/m2 n = 6	Part 1 and Part 2: Calaspargase Pegol (S95015) 1500 U/m2 n = 11	Part 1: Calaspargase Pegol (S95015) 1000 U/m2 (≥ 55 Years) n = 8	Part 1: Calaspargase Pegol (S95015) 1000 U/m2 (<55 Years) n = 8
Remission Induction - 7 Days After Last Administration	0.5911 (0.20849)	0.6487 (0.17169)	0.4121 (0.18586)	0.2398 (0.17743)	0.2523 (0.16662)
Remission Induction - 14 Days After Last Administration	0.4182 (0.17508)	0.3711 (0.27162)	0.2651 (0.14810)	0.1487 (0.07612)	0.1550 (0.11047)
Remission Induction - 21 Days After Last Administration	0.2894 (0.14610)	0.2702 (0.16674)	0.2097 (0.13352)	0.1093 (0.05684)	0.0573 (0.04991)
Remission Consolidation - 7 Days After Last Administration	0.4851 (0.33448)	0.8412 (0.42075)	0.4835 (0.26977)	0.4072 (0.15454)	0.2181 (0.22531)
Remission Consolidation - 14 Days After Last Administration	0.4271 (0.29779)	0.5078 (0.35939)	0.3846 (0.21038)	0.2282 (0.13321)	0.1847 (0.20467)
Remission Consolidation - 21 Days After Last Administration	0.3318 (0.26791)	0.5445 (0.03688)	0.2664 (0.16542)	0.1567 (0.08777)	0.1125 (0.12338)

Population analysed: The number analyzed in rows differs from the overall number analyzed due to missing participant data.

Primary outcome: Nadir Plasma Asparaginase Activity (NPAA) (Part 2)

Time frame: Day 64 (Remission Consolidation Phase Day 36-91 post baseline).. Count of participants. Unit: Participants

Measure	Combined: Calaspargase Pegol (S95015) 1750 U/m2 and 1500 U/m2 n = 5
Value	5

Population analysed: As pre-specified in the statistical analysis plan and protocol, the primary nadir plasma asparaginase activity (PNPAA) analysis set (PAS) is used which combines all evaluable participants aged 22 to 39 years and BMI ≤ 35 kg/m² + aged 40 to 54 years and BMI ≤ 35 kg/m² who are treated at the recommended dose levels. This combines the participants from the "Part 2: Calaspargase Pegol (S95015) 1750 U/m2" and "Part 1 and Part 2: Calaspargase Pegol (S95015) 1500 U/m2" arms who meet the above criteria.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, approximately 3.5 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 2: Calaspargase Pegol (S95015) 1750 U/m2	8 of 9 (88.9%)	9 of 9 (100%)	0 of 9
Part 1 and Part 2: Calaspargase Pegol (S95015) 1500 U/m2	7 of 11 (63.6%)	11 of 11 (100%)	1 of 11
Part 1: Calaspargase Pegol (S95015) 2000 U/m2	2 of 6 (33.3%)	6 of 6 (100%)	1 of 6
Part 1: Calaspargase Pegol (S95015) 1000 U/m2 (≥ 55 Years)	6 of 8 (75%)	8 of 8 (100%)	3 of 8
Part 1: Calaspargase Pegol (S95015) 1000 U/m2 (<55 Years)	5 of 8 (62.5%)	8 of 8 (100%)	2 of 8

Limitations and caveats (from the sponsor): The results, especially for EFS, DFS, OS and the antibody data (outcome measures 13 to 16) should be interpreted with caution due to the low number of patients by group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundStock W, Park JH, Emadi A, Abdul-Hay M, Cassaday RD, Pullarkat VA, Webster J, Pandya SS, Mogul MJ, Shvenke Y, Zhu JJ, Tessier A, DeAngelo DJ. Safety and Pharmacokinetics of Calaspargase Pegol in Adults with Newly Diagnosed Philadelphia-Negative ALL: A Phase 2/3 Study. Blood. 2021 Nov 23;138(Supplement 1):4406. doi: https://doi.org/10.1182/blood-2021-149463
Derived from this study: PubMed 41074700Aldoss I, Ali A, Cassaday RD, Curran EK, Luskin MR, Maese LD, Orgel E, Douer D. Optimizing Asparaginase Treatment for Adolescent and Young Adult (AYA) Patients With Acute Lymphoblastic Leukemia: US Consensus Panel Recommendations. Am J Hematol. 2026 Jan;101(1):41-55. doi: 10.1002/ajh.70103. Epub 2025 Oct 11.
Find Results on Servier Clinical Trial Data websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified scientific and medical researchers can request access to anonymized patient-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 patients: * sponsored by Servier * with a first patient 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel J. DeAngelo, MD, PhD principal investigator

Dana-Farber Cancer Institute, Boston, MA

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Calaspargase pegol (S95015) in people with Acute Lymphoblastic Leukemia, run by Institut de Recherches Internationales Servier at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: Through study completion, approximately 3.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04817761, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.