#1 Clinical Trials Search in Europe

Crisantaspase

Crisantaspase, also known as Erwinase or asparaginase Erwinia chrysanthemi, is an enzyme drug being studied in clinical trials for the treatment of acute lymphoblastic leukemia (ALL). It is used as an alternative treatment for patients who develop hypersensitivity to E. coli-derived asparaginase. This article summarizes key information from recent clinical trials investigating the use of crisantaspase in ALL patients.

Table of Contents

What is Crisantaspase?

Crisantaspase, also known as Asparaginase Erwinia chrysanthemi, is a medication used in the treatment of certain blood cancers. It belongs to a class of drugs called asparaginase enzymes. This medication has several other names you might hear, including:

  • Erwinase
  • Erwinaze
  • Asparaginase Erwinia chrysanthemi (recombinant)-rywn
  • Recombinant Crisantaspase JZP-458
  • Rylaze

These different names refer to the same medication or slightly modified versions of it[1][2]. Your healthcare provider may use any of these terms when discussing this treatment with you.

What Conditions Does Crisantaspase Treat?

Crisantaspase is primarily used to treat certain types of leukemia and lymphoma, specifically:

  • Acute Lymphoblastic Leukemia (ALL): This is a type of blood cancer that affects the white blood cells called lymphocytes. It progresses quickly and requires immediate treatment.
  • Lymphoblastic Lymphoma: This is a type of cancer that affects the lymphatic system, which is part of the body’s immune system.

Crisantaspase is often used when patients have had an allergic reaction to or cannot tolerate other forms of asparaginase therapy, such as those derived from E. coli bacteria[3][4]. It’s particularly valuable for patients who need to continue asparaginase therapy but have developed hypersensitivity to E. coli-derived asparaginase.

How Does Crisantaspase Work?

Crisantaspase works by breaking down an amino acid called asparagine. Cancer cells need asparagine to grow and multiply, but they can’t make it themselves. Normal cells can make their own asparagine, so they’re less affected by the treatment.

By depleting asparagine in the blood, crisantaspase essentially “starves” the cancer cells, preventing them from growing and dividing[4]. This process helps to slow down or stop the progression of the cancer.

How is Crisantaspase Administered?

Crisantaspase is typically given as an injection. Depending on the specific formulation and treatment plan, it may be administered in one of the following ways:

  • Intramuscular (IM) injection: The medication is injected into a muscle.
  • Intravenous (IV) infusion: The medication is given directly into a vein over a period of time.

The dosage and frequency of administration can vary based on factors such as the patient’s body surface area, the specific condition being treated, and how well the patient tolerates the medication[3][5].

Current Clinical Trials

Several clinical trials are currently exploring the use of crisantaspase in different treatment regimens and patient populations. These trials aim to improve our understanding of how to best use this medication and potentially expand its applications. Some notable ongoing research includes:

  • Studies comparing different dosing schedules to optimize efficacy and minimize side effects[5].
  • Trials investigating the use of crisantaspase in combination with other chemotherapy drugs[2].
  • Research on using crisantaspase in patients who have relapsed (cancer has returned) or have refractory disease (cancer that doesn’t respond to initial treatment)[1].

Potential Side Effects

Like all medications, crisantaspase can cause side effects. Some of the potential side effects include:

  • Allergic reactions: These can range from mild to severe and may include rash, difficulty breathing, or swelling.
  • Liver problems: Crisantaspase can affect liver function. Your doctor will monitor your liver health during treatment.
  • Pancreas inflammation (pancreatitis): This can cause abdominal pain and requires immediate medical attention.
  • Blood clotting issues: The medication can affect your body’s ability to form blood clots.
  • Nausea and vomiting
  • Fever

Your healthcare team will closely monitor you for these and other potential side effects throughout your treatment[6].

Important Considerations

When receiving crisantaspase treatment, there are several important things to keep in mind:

  • Medical history: Inform your doctor about any allergies, liver problems, or pancreas issues you’ve had in the past.
  • Monitoring: Regular blood tests will be necessary to check your liver function, blood clotting ability, and other important health indicators.
  • Pregnancy and breastfeeding: If you’re pregnant, planning to become pregnant, or breastfeeding, discuss this with your doctor as crisantaspase may not be suitable.
  • Other medications: Tell your healthcare provider about all medications, vitamins, and supplements you’re taking, as crisantaspase can interact with other drugs.
  • Follow-up care: After completing treatment, you’ll need regular check-ups to monitor for any long-term effects and to ensure the cancer remains in remission[7].

Remember, while this information provides a general overview, your specific treatment plan may vary. Always consult with your healthcare team for personalized advice and information about your treatment with crisantaspase.

Trial Aspect Details
Patient Populations Pediatric and adult ALL patients with hypersensitivity to E. coli asparaginase
Dosing 25,000 IU/m2 intramuscularly or intravenously, often 3x/week
Key Outcomes Serum asparaginase activity, MRD, event-free survival, overall survival
Safety Findings Generally well-tolerated; monitoring for allergic reactions required
Efficacy Results Appears effective for maintaining therapeutic asparaginase activity levels

FAQ

  • What is crisantaspase? Crisantaspase is an enzyme drug derived from Erwinia chrysanthemi bacteria. It depletes asparagine in the blood, which leukemia cells need to survive. It is used as an alternative to E. coli-derived asparaginase in patients who develop allergic reactions.
  • How is crisantaspase administered? Crisantaspase is typically administered intramuscularly or intravenously. The dosing schedule varies but is often given 3 times per week on a Monday/Wednesday/Friday schedule.
  • What types of patients are being studied with crisantaspase? Clinical trials are studying crisantaspase in pediatric and adult patients with acute lymphoblastic leukemia who have developed hypersensitivity to E. coli-derived asparaginase. Some trials also include patients with lymphoblastic lymphoma.
  • What are the main outcomes being measured in crisantaspase trials? Key outcomes include serum asparaginase activity levels, minimal residual disease, event-free survival, overall survival, pharmacokinetics, and safety/tolerability of the drug.
  • How does crisantaspase compare to other asparaginase treatments? Crisantaspase appears to be an effective alternative for patients who cannot tolerate E. coli-derived asparaginase. However, more research is needed to directly compare efficacy and long-term outcomes between the different asparaginase formulations.

Ongoing Clinical Trials on Crisantaspase

  • Study of Blinatumomab and a drug combination for older adults with newly diagnosed Philadelphia-negative B-cell precursor Acute Lymphoblastic Leukemia

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Denmark Estonia +11

  • Study Comparing Inotuzumab Ozogamicin to Drug Combination for Children with High-Risk Relapsed B-cell Acute Lymphoblastic Leukemia

    Recruiting

    2 1 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +10

  • Study on Improving Treatment for Children and Adolescents with Acute Lymphoblastic Leukemia Using Bortezomib, Blinatumomab, and a Drug Combination

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Czechia Germany Italy Slovakia

  • Study on Imatinib and Chemotherapy Combination for Children with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +6

  • Study on Acute Lymphoblastic Leukemia Treatment in Children and Adolescents Using Bortezomib, Blinatumomab, and Methotrexate Combination

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Poland

Glossary

  • Acute lymphoblastic leukemia (ALL): A type of blood cancer that affects white blood cells called lymphocytes. It progresses rapidly without treatment.
  • Asparaginase: An enzyme that breaks down asparagine, an amino acid that leukemia cells need to survive. Depleting asparagine in the blood can kill leukemia cells.
  • Crisantaspase: An asparaginase enzyme derived from Erwinia chrysanthemi bacteria. Used as an alternative to E. coli-derived asparaginase in patients with hypersensitivity.
  • Hypersensitivity: An exaggerated immune response to a drug, often resulting in allergic reactions.
  • Minimal residual disease (MRD): Small numbers of cancer cells that remain after treatment, often undetectable by standard tests. Used to assess treatment efficacy.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism and excretion.
  • Serum asparaginase activity: A measure of how much active asparaginase enzyme is present in the blood. Used to assess if therapeutic levels are being maintained.

References

  1. https://clinicaltrials.gov/study/NCT02981628
  2. https://clinicaltrials.gov/study/NCT02553460
  3. https://clinicaltrials.gov/study/NCT02150928
  4. https://clinicaltrials.gov/study/NCT04943952
  5. https://clinicaltrials.gov/study/NCT01643408
  6. https://clinicaltrials.gov/study/NCT02647190
  7. https://clinicaltrials.gov/study/NCT03164057