Calaspargase Pegol for Acute Lymphoblastic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing Calaspargase pegol, a medication for treating a specific type of blood cancer called Philadelphia-negative Acute Lymphoblastic Leukemia. The study aims to find the best dose and check the safety of the drug. Calaspargase pegol works by starving the cancer cells of a nutrient they need to survive.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had prior therapy for ALL, except for limited corticosteroids or hydroxyurea treatment and a single dose of intrathecal cytarabine.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that you should not have had prior therapy for ALL, except for limited treatment with corticosteroids or hydroxyurea.
What safety data is available for Calaspargase Pegol in treating Acute Lymphoblastic Leukemia?
Calaspargase Pegol, approved by the FDA in December 2018 for treating acute lymphoblastic leukemia (ALL) in children and young adults, has been evaluated for safety in several studies. The Dana-Farber Cancer Institute Protocol 11-001 compared its efficacy and toxicity to pegaspargase, showing a similar safety profile. The Children's Oncology Group Study AALL07P4 also assessed its pharmacokinetics and pharmacodynamics, confirming its comparability to pegaspargase. The FDA approval was based on maintaining steady-state nadir serum asparaginase activity, with no substantial impairment in event-free survival compared to pegaspargase. Overall, Calaspargase Pegol has demonstrated a safety profile similar to existing treatments.12345
Is calaspargase pegol safe for use in humans?
Calaspargase pegol has been approved by the FDA for treating acute lymphoblastic leukemia in children and young adults, and studies show it has a similar safety profile to the standard treatment, pegaspargase. This means it is generally considered safe when used as part of a multi-drug treatment plan for this condition.12345
Is the drug Calaspargase pegol a promising treatment for Acute Lymphoblastic Leukemia?
Yes, Calaspargase pegol is a promising drug for treating Acute Lymphoblastic Leukemia. It has been approved by the FDA for use in children and young adults, showing similar safety and effectiveness compared to existing treatments. It has a longer-lasting effect, which means it can be given less frequently, making it more convenient for patients.12346
How is the drug Calaspargase Pegol different from other treatments for acute lymphoblastic leukemia?
What data supports the idea that Calaspargase Pegol for Acute Lymphoblastic Leukemia is an effective drug?
The available research shows that Calaspargase Pegol is effective in treating Acute Lymphoblastic Leukemia (ALL) in children and young adults. It was approved by the FDA based on its ability to maintain necessary enzyme levels in the blood, which is crucial for successful treatment. In a study, 99% of patients maintained these levels over several weeks, indicating its effectiveness. Additionally, when compared to another drug, Pegaspargase, Calaspargase Pegol had a similar safety profile and did not negatively impact the patients' chances of staying free from the disease.12347
What data supports the effectiveness of the drug Calaspargase Pegol for treating Acute Lymphoblastic Leukemia?
Calaspargase Pegol has been shown to maintain necessary enzyme activity levels in nearly all patients, which is important for treating Acute Lymphoblastic Leukemia (ALL). It has a similar safety profile to another standard treatment, Pegaspargase, and does not negatively impact event-free survival, making it an effective option for children and young adults with ALL.12348
Who Is on the Research Team?
Daniel DeAngelo, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute, Boston, MA
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Remission Induction
Participants receive Calaspargase pegol to induce remission
Remission Consolidation
Participants continue treatment to consolidate remission
Interim Maintenance
Participants receive maintenance therapy to sustain remission
Delayed Intensification
Participants undergo intensified treatment to prevent relapse
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Calaspargase pegol
Calaspargase pegol is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Institut de Recherches Internationales Servier
Lead Sponsor
ADIR, a Servier Group company
Industry Sponsor