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 10 · a red edge is where a trial was stopped

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 → Dec 2025 overdue 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 NCT06317662 Jun 2025 → Dec 2028 expected B-cell acute lymphoblastic leukemia, acute leukemia of ambiguous lineage National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04817761 Jul 2021 → Mar 2025 acute lymphoblastic leukemia Servier Terminated No outcome recorded
Phase 32 trials
Phase 3 NCT03007147 Aug 2017 → Sep 2027 expected 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
Phase not applicable1 trial
NCT01225874 Dec 1999 → Mar 2006 leukemia Children's Oncology Group Completed No outcome recorded
Also used as a comparator or background therapy in 15 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 NCT05326516 Background Mar 2022 → Jul 2024 acute lymphoblastic leukemia, acute undifferentiated leukemia, mixed phenotype acute leukemia Syndax Pharmaceuticals Completed No outcome recorded
Phase 1/21 trial
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 28 trials
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 NCT06124157 Background May 2025 → Dec 2030 expected B-cell acute lymphoblastic leukemia National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 2 NCT06390319 Background Dec 2024 → Dec 2027 expected T-cell acute lymphoblastic leukemia, T-cell non-Hodgkin lymphoma, mixed phenotype acute leukemia St. Jude Children's Research Hospital Recruiting No outcome recorded
Phase 2 NCT06210750 Background Aug 2024 → Sep 2026 T-cell acute lymphoblastic leukemia, T-lymphoblastic lymphoma National Cancer Institute (NCI) Withdrawn No outcome recorded
Phase 2 NCT05761171 Background Jan 2024 → Dec 2027 expected acute lymphoblastic leukemia, mixed phenotype acute leukemia Children's Oncology Group Active not recruiting No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT07072585 Background Aug 2026 → Sep 2035 expected T-cell acute lymphoblastic leukemia, T-lymphoblastic lymphoma Children's Oncology Group Not yet recruiting No outcome recorded
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 32 trials
Phase 3 NCT05602194 Background Aug 2023 → Sep 2026 expected B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), B-lymphoblastic leukemia/lymphoma, BCR-ABL1–like, T-cell acute lymphoblastic leukemia, lymphoblastic lymphoma +1 Children's Oncology Group Active not recruiting No outcome recorded
Phase 3 NCT03959085 Background Oct 2019 → Mar 2032 expected B-cell acute lymphoblastic leukemia, central nervous system leukemia, lymphoblastic lymphoma, mixed phenotype acute leukemia +1 Children's Oncology Group Recruiting No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 26 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

NCT05192889

NCT07072585

NCT06390319

NCT05581030

NCT03959085

NCT07636564

NCT03719105

NCT03007147

NCT05761171

NCT05602194

NCT06210750

NCT06124157

NCT02981628

NCT06317662

NCT04817761

NCT05292664

NCT04546399

NCT03117751

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

NCT04953780

NCT06561074

NCT00671034

NCT05034627

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
Known as SC-PEG E. coli L-asparaginase ClinicalTrials.gov intervention name — accepted as the source's own label NCT01225874
Modality Protein / enzyme biologic “SC-PEG E. Coli L-asparaginase” NCT00671034
Route Intravenous “Given IV” NCT00671034