What side effects are associated with this type of intervention?

Common treatments for Acute Lymphoblastic Leukemia (ALL), such as asparaginase and its derivatives like Calaspargase pegol, often lead to side effects including myelosuppression, which results in decreased production of blood cells and requires frequent blood monitoring. Other side effects can include liver dysfunction, pancreatitis, coagulation abnormalities, and hypersensitivity reactions. General chemotherapy for ALL can also cause gastrointestinal symptoms, infections due to immunosuppression, and peripheral neuropathy.

What prior FDA approvals exist?

The FDA has approved several asparaginase-based treatments for Acute Lymphoblastic Leukemia (ALL). These include E. coli-derived asparaginase, pegylated asparaginase (pegaspargase), and Erwinia asparaginase, which are used to deplete asparagine and inhibit protein synthesis in leukemia cells. Pegaspargase, a pegylated form of L-asparaginase, is commonly used due to its longer half-life and reduced immunogenicity. Additionally, recombinant Erwinia asparaginase is approved for patients who develop hypersensitivity to E. coli-derived asparaginase. These treatments are integral to various chemotherapy regimens for ALL.

What other types of research exist?

One promising alternative to Calaspargase pegol for ALL patients is the GRAALL 2005 regimen, which includes a combination of cyclophosphamide and a chemotherapy backbone. This regimen has shown a high complete remission rate and significant overall survival rates in clinical trials. Another potential alternative is the use of immune checkpoint inhibitors or other targeted therapies that are currently being investigated for their efficacy in ALL.

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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.

Must not have

Known history of non-gallstone-related pancreatitis.

Patients with Philadelphia chromosome positive ALL, Burkitt's leukemia, mixed lineage/mixed phenotype acute leukemia, and acute undifferentiated leukemia per WHO classification (2016).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion an average of 3 months.

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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 below

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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.

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I am 22 or older with a new diagnosis of a specific type of leukemia that is not Philadelphia chromosome positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had pancreatitis not caused by gallstones.

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My leukemia type is recognized by the WHO as needing specific treatment.

Select...

My liver function is severely impaired.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion an average of 3 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events (AEs) (Part 1)

Adverse Events (AEs) (Part 2)

Nadir Plasma Asparaginase Activity (NPAA) (Part 2)

+1 more

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Calaspargase pegol (S95015)Experimental Treatment1 Intervention

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Lymphoblastic Leukemia (ALL) include asparaginase, which depletes asparagine to inhibit protein synthesis in leukemia cells, effectively starving them. This is critical for ALL patients because leukemia cells cannot synthesize asparagine efficiently. Other treatments like vincristine and dexamethasone disrupt cell division and induce apoptosis, targeting the rapid proliferation of leukemia cells to achieve remission and prevent relapse.

Depletion of d- and l-asparagine in cerebrospinal fluid in acute lymphoblastic leukemia during PEGasparaginase therapy.