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Also known as Asparaginase Erwinia chrysanthemi (Recombinant)-rywn, Asparaginase Erwinia chrysanthemi-rywn, Crisantaspase, Crisantaspase Biobetter JZP-458, Crisantaspasum, Enrylaze, Erwinase, Erwinaze
asparaginase Erwinia chrysanthemi · 2 trials · 4 indications
Will be measured by multi-parameter flow cytometry (MFC). Will be assessed according to the National Comprehensive Cancer Network response criteria.
To report the mean 2 day NSAA levels (48 hour levels taken after the 5th dose) that are \> or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.
| Arm | Type | Description |
|---|---|---|
| Treatment (DA-EPOCH, rituximab, JZP458) | EXPERIMENTAL | Patients receive etoposide IV, doxorubicin IV and vincristine IV over 96 hours on days 1-4, cyclophosphamide IV over 1 hour on day 5, prednisone PO BID on days 1-5 of each cycle. In addition, CD20 positive patients receive rituximab IV on day 1 or 5 of each cycle. Patients also receive JZP458 IM every 2-3 days on days 7-21 for up to 7 doses. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 6, 7, or 8, patients also receive pegfilgrastim SC once or filgrastim SC QD until ANC \> 2000/uL past nadir. Patients also undergo blood sample collection and bone marrow collection throughout the study. Additionally, patients with extramedullary disease may undergo CT or PET/CT throughout the study. |
| Open-Label Erwinaze | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Asparaginase Erwinia chrysanthemi | DRUG | Given IM |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Collection | PROCEDURE | Undergo bone marrow sample collection |
| Computed Tomography | PROCEDURE | Undergo CT or PET/CT |
| Cyclophosphamide | DRUG | Given IV |
| Doxorubicin | DRUG | Given CIV |
| Etoposide | DRUG | Given CIV |
| Filgrastim | BIOLOGICAL | Given SC |
| Pegfilgrastim | BIOLOGICAL | Given SC |
| Positron Emission Tomography | PROCEDURE | Undergo PET/CT |
| Prednisone | DRUG | Given PO |
| Rituximab | BIOLOGICAL | Given IV |
| Vincristine | DRUG | Given CIV |
Inclusion Criteria: * Adults (age 18 years and older) with newly-diagnosed Ph- B-ALL or T-ALL * In the opinion of the treating investigator, patients must be an unsuitable candidate for a pediatric-inspired regimen, reasons for which may include (but not be limited to) older age (e.g., ≥ 40 years),...
Asparaginase Erwinia chrysanthemi is used for Acute Lymphoblastic Leukemia, including B Acute Lymphoblastic Leukemia and Philadelphia Chromosome Negative subtypes. It is being studied in patients with these conditions, and one trial also includes Lymphoblastic Lymphoma. The drug is in Phase 2 clinical development for these oncology indications.
Asparaginase Erwinia chrysanthemi is an enzyme that targets asparagine, an amino acid required for leukemia cell growth. By breaking down asparagine, the drug deprives cancer cells of a nutrient they need, which is the basis of its mechanism in treating Acute Lymphoblastic Leukemia.
Asparaginase Erwinia chrysanthemi is developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the stock exchange under the ticker JAZZ. The company is conducting clinical trials to evaluate the drug for the treatment of Acute Lymphoblastic Leukemia.
Asparaginase Erwinia chrysanthemi is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials are listed, one completed and one currently recruiting patients, both studying the drug in leukemia indications.
Asparaginase Erwinia chrysanthemi is being studied in two Phase 2 trials. NCT01643408, a completed study, evaluated the drug given intravenously in patients allergic to frontline asparaginase therapy. NCT06738368, currently recruiting, combines the drug with a chemotherapy regimen for newly diagnosed B or T Acute Lymphoblastic Leukemia.
Asparaginase Erwinia chrysanthemi is also known as Erwinaze, as referenced in the clinical trial title for NCT01643408. The drug is sometimes called recombinant Erwinia asparaginase, and the trial NCT06738368 uses the code name JZP458 for a recombinant form of the enzyme.