Approval Probability
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ML Risk
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 being studied for the treatment of acute lymphoblastic leukemia, including B acute lymphoblastic leukemia that is Philadelphia chromosome negative. It is an investigational drug in clinical development and is not approved for these uses.
Asparaginase Erwinia chrysanthemi is developed by Jazz Pharmaceuticals plc, which trades under the ticker JAZZ. The company is conducting clinical trials to evaluate the drug in patients with acute lymphoblastic leukemia.
Asparaginase Erwinia chrysanthemi is in Phase 2 clinical development. It is being studied in two Phase 2 trials, one of which has been completed and one that is currently recruiting participants.
Asparaginase Erwinia chrysanthemi is being studied in two clinical trials. NCT01643408 is a completed Phase 2 study of Erwinaze given intravenously in patients allergic to frontline asparaginase therapy. NCT06738368 is a recruiting Phase 2 trial combining the drug with chemotherapy for newly diagnosed Philadelphia chromosome negative B acute lymphoblastic leukemia or T acute lymphoblastic leukemia.
Asparaginase Erwinia chrysanthemi is the same as Erwinaze. The completed clinical trial NCT01643408 refers to the drug as Erwinaze, while the recruiting trial NCT06738368 refers to it as recombinant Erwinia asparaginase (JZP458).