Calaspargase Pegol in Adults With ALL
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04817761|
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : December 14, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Drug: Calaspargase pegol (S95015)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||122 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Actual Study Start Date :||July 7, 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||August 2026|
|Experimental: Calaspargase pegol (S95015)||
Drug: 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: S95015 will be administered at doses as confirmed in part 1.
- Adverse Events (AEs) (Part 1) [ Time Frame: From signing the ICF through 30 days after the Calaspargase pegol administration at Day 4 (or Day 5 or Day 6) in the Remission Induction phase. ]Including Treatment-emergent adverse events (TEAEs), adverse events of special interests (AESI); laboratory tests; vital signs; serious adverse events (SAEs) and AE. AEs recoded and evaluated throughout the study in accordance with NCI CTCAE criteria 5.0.
- Adverse Events (AEs) (Part 2) [ Time Frame: From signing the ICF through 30 days after the last dose of the study drug in Delayed Intensification phase. ]Including Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESI); laboratory tests; vital signs; serious adverse events (SAEs) and AEs. AEs recoded and evaluated throughout the study in accordance with NCI CTCAE criteria 5.0.
- Plasma Asparaginase Activity (PAA) level (Part 1) [ Time Frame: Days 4, 5, 6 (Remission Induction phase) for PAA samples. Days 11, 18, 25 (Remission Induction phase) for TDM samples. ]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). ]NPAA level ≥0.1 U/mL 21 days after the Remission Consolidation Phase Day 43 dose.
- Plasma Asparaginase Activity (PAA) level ≥0.1 U/mL at any time during Remission Induction phase and post- Remission Induction phase, respectively (Part 2) [ Time Frame: Days 4-5-6 & 11-18-25 (Remission Induction); Days 15-16-43-44 & 22-29-36-50-57-64 (Consolidation); Days 22-23 & 29-36-43 (Interim Maintenance); Days 4-5,43-44 & 11-18-25-50-57-64 (Delayed Intensification) for PAA & TDM samples respectively. ]Pharmacodynamics criterion.
- Plasma Asparaginase Activity (PAA) level ≥0.025, ≥0.1, ≥0.2, or ≥0.4 U/mL at predefined time points during Remission Induction phase and post- Remission Induction phase, respectively (Part 2) [ Time Frame: Days 4-5-6 & 11-18-25 (Remission Induction); Days 15-16-43-44 & 22-29-36-50-57-64 (Consolidation); Days 22-23 & 29-36-43 (Interim Maintenance); Days 4-5-43-44 & 11-18-25-50-57-64 (Delayed Intensification) for PAA & TDM samples respectively. ]Pharmacodynamics criterion.
- PAA-derived maximum concentration (Cmax) after the Remission Induction Phase Day 4 dose (Part 1 and 2). [ Time Frame: Days 4, 5, 6 & 11, 18, 25 (Remission Induction); for PAA & TDM samples respectively. ]PAA-derived Cmax are based on population modeling analysis.
- PAA-derived Area Under the PAA-Time Curve From Time 0 to Day 21 (AUC 0-21) after the Remission Induction Phase Day 4 dose (Part 1 and 2). [ Time Frame: Days 4, 5, 6 & 11, 18, 25 (Remission Induction); for PAA & TDM samples respectively. ]PAA-derived AUC 0-21 are based on population modeling analysis.
- Minimal residual disease (MRD) (Part 1 and 2) [ Time Frame: End of remission induction phase (Day 29). ]Efficacy criterion.
- Complete remission (CR) (Part 1 and 2) [ Time Frame: Day 29 remission induction therapy ]Morphologic complete remission rate (CR), morphologic complete remission rate with incomplete blood count recovery (CRi).
- Survival (Part 1 and 2) [ Time Frame: Through study completion an average of 3 months. ]
- 1-year EFS (event-free survival), DFS (disease-free survival) and OS (overall survival)
- 2-year EFS, DFS, OS
- 3-year EFS, DFS, OS.
- Anti-drug (calaspargase pegol) antibody (ADA) development (Part 1 and 2) [ Time Frame: D4, D18, D29 (Remission Induction Phase), D15, D43 (Remission Consolidation Phase), D22 (Interim Maintenance Phase), D4, D43 (Delayed Intensification Phase), Day 365 (±7) after the first dose, Day 30 after the last dose if discontinuation. ]Immunogenicity criterion.
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:||22 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Aged ≥22 years 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.
- 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 >10 times ULN.
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): NCT04817761
|Contact: Institut de Recherches Internationales Servier, Clinical Studies Department||+33 1 55 72 43 firstname.lastname@example.org|
|United States, Arizona|
|HonorHealth Cancer Transplant Institute||Withdrawn|
|Scottsdale, Arizona, United States, 85258|
|United States, California|
|City of Hope Comprehensive Cancer Center||Recruiting|
|Duarte, California, United States, 91010|
|Univeristy of California||Recruiting|
|Los Angeles, California, United States, 90095|
|United States, Florida|
|University of Miami Health System - Sylvester Comprehensive Cancer Center||Not yet recruiting|
|Miami, Florida, United States, 33136|
|United States, Illinois|
|University of Chicago Medicine||Recruiting|
|Chicago, Illinois, United States, 60637|
|United States, Kansas|
|University of Kansas Cancer Center - Richard and Annette Bloch Cancer Care Pavilion||Not yet recruiting|
|Westwood, Kansas, United States, 66205|
|United States, Maryland|
|University of Maryland Greenbaum Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact +1 410 614 72|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Weymouth, Massachusetts, United States, 02190|
|United States, New York|
|NYU Langone/Laura and Isaac Perlmutter Cancer Center||Recruiting|
|New York, New York, United States, 10016|
|Weill Cornell Medical College||Withdrawn|
|New York, New York, United States, 10021|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Washington|
|University of Washington/Seattle Cancer Care Alliance||Recruiting|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Daniel J. DeAngelo, MD, PhD||Dana-Farber Cancer Institute, Boston, MA|
Study Data/Documents: Individual Participant Data Set
|Responsible Party:||Institut de Recherches Internationales Servier|
|Other Study ID Numbers:||
|First Posted:||March 26, 2021 Key Record Dates|
|Last Update Posted:||December 14, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||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:
In addition, access can be requested for all interventional clinical studies in patients:
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.|
|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.:||No|
Acute Lymphoblastic Leukemia
Ph-negative B-cell and T cell ALL
Acute Lymphocytic Leukemia
Newly diagnosed ALL
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immune System Diseases