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Enzyme
Calaspargase Pegol for Acute Lymphoblastic Leukemia
Phase 2 & 3
Recruiting
Led By Daniel J. DeAngelo, MD, PhD
Research Sponsored by Institut de Recherches Internationales Servier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of 3 months.
Awards & highlights
Study Summary
This trial is testing a new leukemia treatment to find the best dose and to see if it is safe and effective.
Who is the study for?
Adults aged 22 or older with newly-diagnosed Philadelphia-negative Acute Lymphoblastic Leukemia (ALL) can join this trial. They should be relatively active and able to care for themselves (ECOG PS 0-2). Prior limited treatment for ALL is okay, but those with certain other leukemias, Down syndrome, hepatitis B or C, HIV-positive status, a history of pancreatitis not caused by gallstones, or severe liver issues cannot participate.Check my eligibility
What is being tested?
This phase 2/3 study tests Calaspargase pegol's safety and how the body responds to it in adults with Philadelphia-negative ALL. The goal is to confirm proper dosing levels for effective treatment.See study design
What are the potential side effects?
While specific side effects are not listed here, drugs like Calaspargase pegol may cause reactions at the injection site, liver problems, blood clotting issues, nausea and allergic responses among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had treatment for ALL except possibly short-term steroids, hydroxyurea, or a single dose of intrathecal cytarabine.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 22 or older with a new diagnosis of a specific type of leukemia that is not Philadelphia chromosome positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion an average of 3 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion an average of 3 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events (AEs) (Part 1)
Adverse Events (AEs) (Part 2)
Nadir Plasma Asparaginase Activity (NPAA) (Part 2)
+1 moreSecondary outcome measures
Anti-drug (calaspargase pegol) antibody (ADA) development (Part 1 and 2)
Complete remission (CR) (Part 1 and 2)
Minimal residual disease (MRD) (Part 1 and 2)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Calaspargase pegol (S95015)Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
ADIR, a Servier Group companyIndustry Sponsor
32 Previous Clinical Trials
4,294 Total Patients Enrolled
Institut de Recherches Internationales ServierLead Sponsor
86 Previous Clinical Trials
67,014 Total Patients Enrolled
Daniel J. DeAngelo, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute, Boston, MA
3 Previous Clinical Trials
164 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pancreatitis not caused by gallstones.I haven't had treatment for ALL except possibly short-term steroids, hydroxyurea, or a single dose of intrathecal cytarabine.My leukemia type is recognized by the WHO as needing specific treatment.You have Down syndrome.I can take care of myself and am up and about more than half of my waking hours.I am 22 or older with a new diagnosis of a specific type of leukemia that is not Philadelphia chromosome positive.My liver function is severely impaired.
Research Study Groups:
This trial has the following groups:- Group 1: Calaspargase pegol (S95015)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects will be enrolled in this experiment?
"The trial sponsor, ADIR, needs to enroll 122 patients that meet the full set of inclusion criteria in order to move forward. The Servier Group company will be conducting the study at different sites, including UC San Diego Health Moores Cancer Center and Yale University."
Answered by AI
What other experiments with Calaspargase pegol (S95015) have been completed?
"There are currently six ongoing clinical trials for Calaspargase pegol (S95015), with two of them in Phase 3. Most of the research for this medication is being conducted out of Portland, Oregon, but there are 240 sites running these studies in total."
Answered by AI
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