Drugs / asparaginase
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asparaginase

Protein / enzyme biologic

Developed for
leukemia · acute lymphoblastic leukemia · lymphoma · adult acute lymphoblastic leukemia · myelodysplastic syndrome · acute erythroid leukemia · acute monocytic leukemia · acute myeloblastic leukemia with maturation
+19 more · acute myeloblastic leukemia without maturation · acute myelomonocytic leukemia M4 · childhood acute megakaryoblastic leukemia · childhood acute myeloid leukemia · childhood myelodysplastic syndrome · lymphoid leukemia · acute basophilic leukemia · acute leukemia · acute myeloid leukemia with minimal differentiation · B-cell acute lymphoblastic leukemia · childhood acute lymphoblastic leukemia · childhood malignant neoplasm · lymphoblastic lymphoma · myeloid leukemia associated with down syndrome · nasopharyngeal carcinoma · non-Hodgkin lymphoma · refractory precursor T-lymphoblastic lymphoma/leukemia · T-cell acute lymphoblastic leukemia · T-lymphoblastic lymphoma
Investigated by
National Cancer Institute (NCI) · Children's Oncology Group · Dana-Farber Cancer Institute · GIMEMA Foundation · Goethe University · Boston Children's Hospital
+37 more · Johann Wolfgang Goethe University Hospital · Massachusetts General Hospital · SWOG Cancer Research Network · Alliance for Clinical Trials in Oncology · Brigham and Women's Hospital · Chang Gung Memorial Hospital · Columbia University · Deutsche Krebshilfe e.V., Bonn (Germany) · Dutch Childhood Oncology Group · European Organisation for Research and Treatment of Cancer - EORTC · Grupo Argentino de Tratamiento de la Leucemia Aguda · Hannover Medical School · Italian Association of Pediatric Hematology and Oncology · Laval University · Maine Children's Cancer Program · McMaster University · Medical Research Council · Memorial Sloan Kettering Cancer Center · NCIC Clinical Trials Group · National Hospital Organization Nagoya Medical Center · National Institutes of Health Clinical Center (CC) · Ochsner Health System · PETHEMA Foundation · Queen Elizabeth II Health Sciences Centre · San Jorge Children's Hospital (Puerto Rico) · St. Jude Children's Research Hospital · St. Justine's Hospital · Tulane University School of Medicine · UNICANCER · United Kingdom Children's Cancer Study Group · University Hospital Schleswig-Holstein · University Hospital, Limoges · University Hospital, Motol · University Medical Center Hamburg-Eppendorf · University of Rochester · University of Washington · medac GmbH

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Spectrila — 2016-01-14 europa.eu ↗
Approved US (FDA) ELSPAR — 1978-01-10 fda.gov ↗

Trials 44

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00004056 Oct 1999 → Oct 2002 leukemia Children's Oncology Group Completed No outcome recorded
Phase 215 trials
Phase 2 NCT03668392 Jun 2020 → Dec 2021 acute lymphoblastic leukemia GIMEMA Foundation Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT02538926 Jul 2018 → Jul 2020 B-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic leukemia, T-lymphoblastic lymphoma, adult acute lymphoblastic leukemia +1 University of Washington Withdrawn No outcome recorded
Phase 2 NCT03286634 Apr 2017 → Mar 2028 expected Down syndrome, acute lymphoblastic leukemia, childhood malignant neoplasm National Hospital Organization Nagoya Medical Center Active not recruiting No outcome recorded
Phase 2 NCT00476190 Apr 2007 → Sep 2013 acute lymphoblastic leukemia Dana-Farber Cancer Institute Completed No outcome recorded
Phase 2 NCT00283985 Feb 2006 → Jun 2012 non-Hodgkin lymphoma University Hospital, Limoges Completed No outcome recorded
Phase 2 NCT00109837 Apr 2005 → Nov 2010 leukemia SWOG Cancer Research Network Completed No outcome recorded
Phase 2 NCT00136435 Jun 2002 → Nov 2008 acute lymphoblastic leukemia Dana-Farber Cancer Institute Completed No outcome recorded
Phase 2 NCT00003783 Mar 1999 → Nov 2002 leukemia Children's Oncology Group Completed No outcome recorded
Phase 2 NCT00003700 Jan 1999 → Feb 2004 lymphoid leukemia Alliance for Clinical Trials in Oncology Completed No outcome recorded
Phase 2 NCT00003671 Dec 1998 → Nov 2002 leukemia Children's Oncology Group Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT00002499 Jan 1990 → ? leukemia Grupo Argentino de Tratamiento de la Leucemia Aguda Unknown No outcome recorded
Phase 318 trials · 2 missed
Phase 3 NCT02521493 Dec 2015 → Jun 2024 overdue Down syndrome, myelodysplastic syndrome, myeloid leukemia associated with down syndrome Children's Oncology Group Active not recruiting No outcome recorded
Phase 3 NCT00784017 Oct 2008 → Oct 2012 acute lymphoblastic leukemia medac GmbH Completed No outcome recorded
Phase 3 NCT00369317 Mar 2007 → Dec 2013 acute basophilic leukemia, acute erythroid leukemia, acute monocytic leukemia, acute myeloblastic leukemia with maturation +6 Children's Oncology Group Completed No outcome recorded
Phase 3 NCT00764907 Nov 2002 → Oct 2007 leukemia University Hospital, Motol Unknown No outcome recorded
Phase 3 NCT00165178 Sep 2000 → Dec 2004 childhood acute lymphoblastic leukemia Dana-Farber Cancer Institute Completed No outcome recorded
Phase 3 NCT00613457 Sep 2000 → Jul 2006 leukemia Italian Association of Pediatric Hematology and Oncology Completed Missed primary
Phase 3 NCT00430118 Jul 2000 → Jan 2012 leukemia University Hospital Schleswig-Holstein Completed No outcome recorded
Phase 3 NCT00004228 Jun 2000 → Aug 2008 lymphoma Children's Oncology Group Completed Missed primary
Phase 3 NCT00005603 Mar 2000 → Sep 2005 leukemia Children's Oncology Group Completed No outcome recorded
Phase 3 NCT00003593 Jun 1999 → Mar 2007 leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm Children's Oncology Group Completed No outcome recorded
Phase 45 trials
Phase 4 NCT00199017 Apr 2004 → Mar 2009 lymphoblastic lymphoma Johann Wolfgang Goethe University Hospital Completed No outcome recorded
Phase 4 NCT00198978 Jan 2003 → Jun 2011 adult acute lymphoblastic leukemia Goethe University Completed No outcome recorded
Phase 4 NCT00199056 Oct 1999 → Nov 2003 adult acute lymphoblastic leukemia Goethe University Completed No outcome recorded
Phase 4 NCT00494897 Jun 1996 → May 2007 acute lymphoblastic leukemia PETHEMA Foundation Completed No outcome recorded
Phase 4 NCT00199069 Apr 1993 → Jan 1999 adult acute lymphoblastic leukemia Goethe University Completed No outcome recorded
Phase not applicable4 trials
— NCT06676293 Aug 2023 → Apr 2024 nasopharyngeal carcinoma Chang Gung Memorial Hospital Completed No outcome recorded
— NCT01156883 Apr 2010 → Oct 2017 leukemia GIMEMA Foundation Completed No outcome recorded
— NCT00343369 Jan 2003 → ? leukemia University Medical Center Hamburg-Eppendorf Unknown No outcome recorded
— NCT00537550 Jul 2000 → Jun 2006 acute lymphoblastic leukemia GIMEMA Foundation Completed No outcome recorded
Comparator or background therapy32 trials
Phase 1 NCT00028899 Background Jul 2002 → Sep 2006 leukemia, myelodysplastic syndrome Children's Oncology Group Completed No outcome recorded
Phase 1/2 NCT00061945 Background Jun 2003 → Dec 2007 B-cell adult acute lymphocytic leukemia, B-cell childhood acute lymphoblastic leukemia, T-cell adult acute lymphocytic leukemia, T-cell childhood acute lymphocytic leukemia +1 National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00262925 Background Jun 2006 → Oct 2012 adult acute lymphoblastic leukemia National Cancer Institute (NCI) Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00458848 Background Oct 2004 → Mar 2014 leukemia GIMEMA Foundation Completed No outcome recorded
Phase 2 NCT00070174 Background Dec 2003 → Sep 2006 leukemia Children's Oncology Group Completed No outcome recorded

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 80 sources stand behind the page.

FieldValueCited text
Known as asparaginase ClinicalTrials.gov intervention name — accepted as the source's own label NCT00003423 ↗
70

NCT00002531 ↗

NCT00537550 ↗

NCT00003700 ↗

NCT00002756 ↗

NCT00458848 ↗

NCT00381680 ↗

NCT01230983 ↗

NCT00494897 ↗

NCT00061945 ↗

NCT00400946 ↗

Show 60 more sources

Known as 106977 (Erwinia) “ASP Asparaginase, NSC-109229 (E. coli) or 106977 (Erwinia)” NCT00002704 ↗
Known as ASNase “three currently used asparaginase (ASNase) preparations” PMID 20108339 ↗ Jul 2010
Known as ASP “asparaginase (ASP) IV over 30 minutes or intramuscularly on days 17-28.” NCT00002514 ↗
7

“ASP Asparaginase, NSC-109229 (E. coli) or 106977 (Erwinia)” NCT00002704 ↗

“asparaginase (ASP) IV over 1 hour or intramuscularly (IM)” NCT00550992 ↗

“asparaginase (ASP) IV over 30 minutes” NCT00002531 ↗

“asparaginase (ASP) on days 12-33” NCT00430118 ↗

“asparaginase (ASP) on days 12-33” NCT00613457 ↗

“Asparaginase, ASP, NSC-109229” NCT00002499 ↗

“ASP Asparaginase, NSC-109229” NCT00002691 ↗

Known as Asparaginase medac “native E.coli asparaginase (Asparaginase medac).” PMID 29727043 ↗ May 2018
Known as E. coli Asparaginase ClinicalTrials.gov intervention name — accepted as the source's own label NCT00476190 ↗
2

NCT00187083 ↗

NCT00165178 ↗

Known as E.coli L-asparaginase ClinicalTrials.gov intervention name — accepted as the source's own label NCT01953770 ↗
1

NCT03286634 ↗

Known as EC-Asnase “We assessed the toxicity and efficacy of dexamethasone and a novel dosing method of Escherichia coli L-asparaginase (EC-Asnase) in children and adolescents with newly diagnosed...” PMID 23358966 ↗ Jan 2013
Known as Escherichia coli L-asparaginase “We assessed the toxicity and efficacy of dexamethasone and a novel dosing method of Escherichia coli L-asparaginase (EC-Asnase) in children and adolescents with newly diagnosed...” PMID 23358966 ↗ Jan 2013
Known as Kidrolase ClinicalTrials.gov intervention name — accepted as the source's own label NCT00283985 ↗
Known as native E coli L-asparaginase “intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses” NCT00400946 ↗
Known as NSC-109229 “ASP Asparaginase, NSC-109229 (E. coli) or 106977 (Erwinia)” NCT00002704 ↗
2

“Asparaginase, ASP, NSC-109229” NCT00002499 ↗

“ASP Asparaginase, NSC-109229” NCT00002691 ↗

Known as Oncospar “Patients on Oncospar” NCT03668392 ↗
Modality Protein / enzyme biologic “Asparaginase is a therapeutic enzyme used to treat leukemia and lymphoma” PMID 24970932 ↗ Jun 2014
Route Intramuscular “asparaginase (ASP) IV over 30 minutes or intramuscularly” NCT00002514 ↗
Route Intravenous “asparaginase (ASP) IV over 30 minutes or intramuscularly” NCT00002514 ↗