Drugs / Asparaginase Erwinia chrysanthemi
Asparaginase Erwinia chrysanthemi
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Enrylaze | — | 2023-09-15 | europa.eu ↗ |
| Label expansion | US (FDA) | RYLAZE | — | 2022-11-18 | fda.gov ↗ |
| Approved | US (FDA) | RYLAZE | — | 2021-06-30 | fda.gov ↗ |
Trials 22 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 23 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07059975 Background | Oct 2025 → Oct 2028 expected | childhood acute myeloid leukemia | Joanna Yi | Recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT05292664 Background | Mar 2023 → Jul 2028 expected | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia, lymphoblastic lymphoma, myelodysplastic syndrome +1 | Andrew E. Place, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT01186328 Background | Aug 2010 → Jan 2012 | T-cell acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia | Therapeutic Advances in Childhood Leukemia Consortium | Terminated | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT05192889 Background | Aug 2022 → Jun 2024 overdue | acute lymphoblastic leukemia | St. Jude Children's Research Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04501614 Background | Feb 2021 → Dec 2023 | B-lymphoblastic leukemia/lymphoma, BCR-ABL1–like, childhood acute lymphoblastic leukemia, mixed phenotype acute leukemia with t(9;22)(q34.1;q11.2) | Takeda | Terminated | No outcome recorded |
| Phase 1/2 | NCT03817320 Background | Feb 2019 → Dec 2023 overdue | childhood acute lymphoblastic leukemia | Therapeutic Advances in Childhood Leukemia Consortium | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02553460 Background | Jan 2016 → May 2022 overdue | acute lymphoblastic leukemia | St. Jude Children's Research Hospital | Active not recruiting | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT06317662 Background | Jun 2025 → Dec 2028 expected | B-cell acute lymphoblastic leukemia, acute leukemia of ambiguous lineage | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05748171 Comparator | May 2023 → May 2033 expected | precursor B-cell acute lymphoblastic leukemia | Pfizer | Recruiting | No outcome recorded |
| Phase 2 | NCT04546399 Background | Dec 2020 → Jun 2028 expected | Down syndrome, acute lymphoblastic leukemia | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06336395 Background | Mar 2020 → Mar 2030 expected | B-cell acute lymphoblastic leukemia | National University Hospital, Singapore | Recruiting | No outcome recorded |
| Phase 2 | NCT02981628 Background | Jun 2017 → Dec 2026 expected | B-cell acute lymphoblastic leukemia | Children's Oncology Group | Recruiting | No outcome recorded |
| Phase 2 | NCT03164057 Background | Jun 2017 → Sep 2025 overdue | acute myeloid leukemia, myelodysplastic syndrome | St. Jude Children's Research Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02723994 Background | Sep 2016 → Mar 2026 | leukemia | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02419755 Background | Apr 2015 → Dec 2016 | acute lymphoblastic leukemia, mixed phenotype acute leukemia | St. Jude Children's Research Hospital | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03117751 Background | Mar 2017 → Sep 2026 expected | lymphoblastic leukemia, acute, with lymphomatous features | St. Jude Children's Research Hospital | Active not recruiting | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT04293562 Background | Jul 2020 → Jun 2029 expected | acute myeloid leukemia | Children's Oncology Group | Recruiting | No outcome recorded |
| Phase 3 | NCT03914625 Background | Jul 2019 → Sep 2027 expected | B-cell acute lymphoblastic leukemia, Down syndrome, lymphoblastic lymphoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03643276 Background | Jul 2018 → Jul 2028 expected | childhood acute lymphoblastic leukemia | Martin Schrappe | Recruiting | No outcome recorded |
| Phase 3 | NCT03020030 Background | Mar 2017 → Nov 2026 expected | childhood acute lymphoblastic leukemia | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02393859 Comparator | Nov 2015 → Jul 2019 | acute lymphoblastic leukemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00549848 Background | Oct 2007 → Sep 2020 | acute lymphoblastic leukemia | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00590915 Background | — | acute lymphoblastic leukemia | Phoenix Children's Hospital | No longer available | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 48 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Asparaginase Erwinia chrysanthemi | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06918431 ↗ |
| Known as | Asparaginase Erwinia Chrysanthemi (recombinant) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04943952 ↗ |
| Known as | asparaginase erwinia chrysanthemi [recombinant]-rywn | “AALL1931, a phase 2/3 study conducted in collaboration with the Children's Oncology Group, investigated the efficacy and safety of JZP458 (asparaginase erwinia chrysanthemi...” PMID 36108304 ↗ Feb 2023 |
| Known as | Cirsantaspase | “switch to Erwinia asparaginase/Cirsantaspase 25 000 U/m² with the same drug regimen” NCT03599960 ↗ |
| Known as | Crisantaspase | “Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase?; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic...” NCT00537030 ↗1“Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)” NCT02150928 ↗ |
| Known as | Enrylaze | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07522801 ↗ |
| Known as | Erwinase | “Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase?; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic...” NCT00537030 ↗12“Patient with allergic reaction to Pegaspargase can be given Erwinase IM/IV on Mon/Wed/Fri (or every other day per institutional standard) x 6 doses for each dose of Pegaspargase” NCT03817320 ↗ “Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)” NCT02150928 ↗ “Drug: Erwinase®” NCT03117751 ↗ “Drug: Erwinase” NCT06336395 ↗ |
| Known as | Erwinaze | “Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)” NCT02150928 ↗ |
| Known as | Erwinia asparaginase | “Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase?; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic...” NCT00537030 ↗13“Chemotherapy agents for reinduction include vincristine, dexamethasone, polyethylene glycol (PEG)-asparaginase (Erwinia asparaginase when PEG-asparaginase is not available),...” NCT04501614 ↗ “BACKGROUND: Erwinia asparaginase is antigenically distinct from E.coli-derived asparaginase and may be used after E.coli-derived asparaginase hypersensitivity.” PMID 26376459 ↗ Sep 2015 “each dose of PEG-asparaginase will be replaced by Erwinia-asparaginase at a dose of 20,000 units/m² IV or IM every other day for a total of 6 doses” NCT05748171 ↗ “switch to Erwinia asparaginase/Cirsantaspase 25 000 U/m² with the same drug regimen” NCT03599960 ↗ |
| Known as | Erwinia L-asparaginase | “Erwinia L-asparaginase may be substituted for pegaspargase” NCT01186328 ↗ |
| Known as | IND 290 | “Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase?; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic...” NCT00537030 ↗ |
| Known as | JZP458 | “AALL1931, a phase 2/3 study conducted in collaboration with the Children's Oncology Group, investigated the efficacy and safety of JZP458 (asparaginase erwinia chrysanthemi...” PMID 36108304 ↗ Feb 2023 |
| Known as | recombinant Erwinia asparaginase | “This phase I/Ib trial tests the safety and side effects of asparaginase Erwinia chrysanthemi-recombinant-rywn (recombinant Erwinia asparaginase) and venetoclax in combination...” NCT07133997 ↗ |
| Action | Inhibit | “JZP458 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.” NCT06738368 ↗ |
| Modality | Protein / enzyme biologic | “Asparaginase is a therapeutic enzyme used to treat leukemia and lymphoma” PMID 24970932 ↗ Jun 2014 |
| Route | Intramuscular | “E. coli asparaginase 10,000 U/m2/day IM (or Erwinia if previous allergy to E. coli)” NCT00187083 ↗ |