Drugs / Calaspargase Pegol

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) ASPARLAS — 2018-12-20 fda.gov ↗

Trials 9

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03719105 Mar 2019 → Dec 2027 expected aggressive NK-cell leukemia New York Medical College Recruiting No outcome recorded
Phase 13 trials
Phase 1 NCT05581030 May 2023 → Oct 2026 expected acute lymphoblastic leukemia H. Lee Moffitt Cancer Center and Research Institute Recruiting No outcome recorded
Phase 1 NCT05034627 Aug 2022 → Dec 2025 overdue pancreatic adenocarcinoma OHSU Knight Cancer Institute Active not recruiting No outcome recorded
Phase 1 NCT04953780 Sep 2021 → Feb 2030 expected acute myeloid leukemia West Virginia University Active not recruiting No outcome recorded
Phase 22 trials
Phase 2 NCT06561074 Sep 2025 → Dec 2029 expected T-cell acute lymphoblastic leukemia, T-lymphoblastic lymphoma M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT02981628 Jun 2017 → Dec 2026 expected B-cell acute lymphoblastic leukemia Children's Oncology Group Active not recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04817761 Jul 2021 → Mar 2025 acute lymphoblastic leukemia Servier Terminated No outcome recorded Stop: Business
Phase 32 trials
Phase 3 NCT03007147 Aug 2017 → Jun 2026 overdue B-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic leukemia, mixed phenotype acute leukemia Children's Oncology Group Active not recruiting No outcome recorded
Phase 3 NCT00671034 Jul 2008 → Feb 2011 B-cell adult acute lymphocytic leukemia, B-cell childhood acute lymphoblastic leukemia Children's Oncology Group Completed No outcome recorded
Comparator or background therapy15 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 NCT05326516 Background Mar 2022 → Jul 2024 acute lymphoblastic leukemia, acute undifferentiated leukemia, mixed phenotype acute leukemia Syndax Pharmaceuticals Completed No outcome recorded
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 2 NCT07636564 Background Oct 2026 → Apr 2031 expected B-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic leukemia, acute leukemia of ambiguous lineage SWOG Cancer Research Network Not yet recruiting No outcome recorded
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

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 25 sources stand behind the page.

FieldValueCited text
Known as Calaspargase Pegol “Patients in this arm were randomized to receive IV Calaspargase Pegol (SC-PEG) 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction.” NCT01574274 ↗
18

NCT04546399 ↗

NCT06317662 ↗

NCT02981628 ↗

NCT04817761 ↗

NCT06124157 ↗

NCT07072585 ↗

NCT07636564 ↗

NCT05292664 ↗

NCT05602194 ↗

NCT05192889 ↗

Show 8 more sources

Known as Asparlas ChEMBL registry synonym — accepted as the source's own label CHEMBL2108728 ↗
Known as Calaspargasa pegol ChEMBL registry synonym — accepted as the source's own label CHEMBL2108728 ↗
Known as Calaspargase Pegol-mknl “During Cycle 1, participants will receive prednisone, vincristine, pegaspargase/calaspargase pegol-mknL, and daunorubicin.” NCT05326516 ↗
4

NCT00671034 ↗

NCT05034627 ↗

NCT04953780 ↗

NCT06561074 ↗

Known as EZN-2285 ChEMBL registry synonym — accepted as the source's own label CHEMBL2108728 ↗
Known as SC-PEG “Patients in this arm were randomized to receive IV Calaspargase Pegol (SC-PEG) 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction.” NCT01574274 ↗
Modality Protein / enzyme biologic “SC-PEG E. Coli L-asparaginase” NCT00671034 ↗
Route Intravenous “Given IV” NCT00671034 ↗