L-Asparaginase Clinical Trials

Size	Price	Qty
1mg	USD 197

Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate the therapeutic application of L-asparaginase as both monotherapy and combination chemotherapy. Key conditions under investigation encompass hematological malignancies and solid tumors, such as acute lymphoblastic leukemia, extranodal NK/T-cell lymphoma, acute myelocytic leukemia, triple-negative breast cancer, and ovarian neoplasms. Sponsored by both academic institutions and industry partners, these studies feature completed, active, and terminated recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06099366	RECRUITING	Lymphoblastic Leukemia in Children	Hee Young Ju	2024-03-05	PHASE2
NCT06336395	RECRUITING	B Lymphoblastic Leukemia	National University Hospital, Singapore	2020-03-04	PHASE2
NCT03286634	ACTIVE_NOT_RECRUITING	Down Syndrome; Acute Lymphoblastic Leukemia; Childhood Cancer	National Hospital Organization Nagoya Medical Center	2017-04-18	PHASE2
NCT03150693	RECRUITING	B Acute Lymphoblastic Leukemia	Alliance for Clinical Trials in Oncology	2017-09-20	PHASE3
NCT04440267	RECRUITING	Acute Leukemia of Ambiguous Lineage	Institute of Hematology & Blood Diseases Hospital, China	2020-07-08	PHASE2
NCT03156790	TERMINATED	Acute B-Cell Lymphoblastic Leukaemia	medac GmbH	2019-04-26	PHASE2
NCT03246750	COMPLETED	Extranodal NK/T-cell Lymphoma	The Thai Lymphoma Study Group	2019-01-30	PHASE1; PHASE2
NCT03599960	UNKNOWN	Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)	Centre Hospitalier Universitaire de Besancon	2019-05-02	PHASE2
NCT03860844	TERMINATED	Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia	Sanofi	2019-08-06	PHASE2
NCT03674242	TERMINATED	Triple Negative Breast Cancer	ERYtech Pharma	2019-06-13	PHASE2; PHASE3
NCT01117441	COMPLETED	Leukemia	University Hospital Schleswig-Holstein	2010-06	PHASE3
NCT02544425	UNKNOWN	Extranodal NK-T-Cell Lymphoma	Samsung Medical Center	2016-02-21	PHASE2
NCT03071822	UNKNOWN	Peripheral T Cell Lymphoma	The University of Hong Kong	2017-02-24	PHASE4
NCT03618238	COMPLETED	Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	2018-07-25	PHASE2
NCT03154918	UNKNOWN	Lymphoma, Extranodal NK-T-Cell	Sichuan University	2017-06-01	PHASE2
NCT03613428	UNKNOWN	Acute T Cell Leukemia	Sichuan University	2018-12-01	PHASE1; PHASE2
NCT00549848	COMPLETED	Acute Lymphoblastic Leukemia	St. Jude Children's Research Hospital	2007-10-29	PHASE3
NCT04230330	WITHDRAWN	NK/T Cell Lymphoma	National Cancer Centre, Singapore	2019-12-12	PHASE1
NCT03623087	UNKNOWN	Non-Hodgkin's Lymphoma, Relapsed; Non-Hodgkin T-cell Lymphoma; Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type	The University of Hong Kong	2017-07-01	PHASE3
NCT02036489	COMPLETED	Acute Lymphobkastic Leukemia	PETHEMA Foundation	2008-01	PHASE4
NCT02894645	UNKNOWN	Acute Lymphoblastic Leukemia (ALL)	National University Hospital, Singapore	2008-10	PHASE4
NCT01910428	TERMINATED	Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma	ERYtech Pharma	2013-10	PHASE1
NCT01810705	COMPLETED	Acute Myeloid Leukemia	ERYtech Pharma	2013-02	PHASE2
NCT02195180	COMPLETED	Pancreatic Adenocarcinoma Metastatic	ERYtech Pharma	2014-07	PHASE2
NCT01878708	TERMINATED	T-Cell Lymphoma; Relapsed T-Cell Lymphoma; Refractory T-Cell Lymphoma	Dana-Farber Cancer Institute	2013-07	EARLY_PHASE1
NCT02419755	TERMINATED	Mixed Lineage Acute Leukemia; Acute Myeloid Leukemia; Acute Lymphoid Leukemia	St. Jude Children's Research Hospital	2015-04-14	PHASE2
NCT01193933	UNKNOWN	Ph-negative Adult Acute Lymphoblastic Leukemia	National Research Center for Hematology, Russia	2008-11
NCT00186875	COMPLETED	Acute Lymphoblastic Leukemia; Lymphoma, Lymphoblastic	St. Jude Children's Research Hospital	2003-11	PHASE2
NCT00526175	COMPLETED	Acute Lymphoblastic Leukemia	PETHEMA Foundation	2001-06	PHASE4
NCT00905034	COMPLETED	Leukemia, Lymphocytic, Acute	M.D. Anderson Cancer Center	2009-03	PHASE2
NCT01953770	UNKNOWN	Childhood Acute Lymphoblastic Leukemia	Federal Research Institute of Pediatric Hematology, Oncology and Immunology	2008-02
NCT01238159	COMPLETED	Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type	Samsung Medical Center	2010-08	PHASE2
NCT01990807	UNKNOWN	Childhood Acute Lymphoblastic Leukemia; Philadelphia Chromosome, Ph^1^, Absent; B-cell Childhood Acute Lymphoblastic Leukemia	Chinese Academy of Medical Sciences	2012-10	PHASE4
NCT00526409	COMPLETED	Acute Lymphoblastic Leukemia	PETHEMA Foundation	2005-06	PHASE4
NCT01518517	COMPLETED	Acute Lymphoblastic Leukemia, in Relapse	ERYtech Pharma	2009-12	PHASE2; PHASE3
NCT00873093	COMPLETED	B-cell Adult Acute Lymphoblastic Leukemia; B-cell Childhood Acute Lymphoblastic Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Lymphoblastic Lymphoma; T-cell Adult Acute Lymphoblastic Leukemia; T-cell Childhood Acute Lymphoblastic Leukemia	National Cancer Institute (NCI)	2009-03	PHASE2
NCT00195871	UNKNOWN	Lymphoblastic Lymphoma	Centre Henri Becquerel	2004-02	PHASE2
NCT01358253	COMPLETED	Acute Lymphoblastic Leukemia	Ruijin Hospital	2010-12	PHASE4
NCT00262925	TERMINATED	Recurrent Adult Acute Lymphoblastic Leukemia	National Cancer Institute (NCI)	2006-06	PHASE2
NCT00933673	UNKNOWN	Lymphoma	Fudan University	2009-06	PHASE2
NCT00283985	COMPLETED	Lymphoma, Non-Hodgkin	University Hospital, Limoges	2006-02	PHASE2
NCT00506597	COMPLETED	Leukemia	M.D. Anderson Cancer Center	2007-05
NCT00854425	COMPLETED	Lymphoma	Fudan University	2008-06	PHASE2
NCT01313078	COMPLETED	Ovarian Neoplasms; Fallopian Tube Neoplasms; Primary Peritoneal Neoplasms	National Cancer Institute (NCI)	2010-01	PHASE2
NCT00131053	UNKNOWN	Lymphoblastic Leukemia, Acute	Japan Adult Leukemia Study Group	2002-09	PHASE2
NCT00098839	COMPLETED	Recurrent Childhood Acute Lymphoblastic Leukemia	Children's Oncology Group	2005-02	PHASE1; PHASE2
NCT00131027	UNKNOWN	Lymphoblastic Leukemia, Acute	Japan Adult Leukemia Study Group	2002-09	PHASE3
NCT01523808	COMPLETED	Pancreatic Cancer	ERYtech Pharma	2009-11	PHASE1
NCT00671034	COMPLETED	Acute Lymphoblastic Leukemia; Adult B Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia	Children's Oncology Group	2008-07-21	PHASE3
NCT01523782	COMPLETED	Acute Lymphoblastic Leukemia	ERYtech Pharma	2009-04	PHASE2
NCT00137111	COMPLETED	Lymphoblastic Leukemia, Acute	St. Jude Children's Research Hospital	2000-07-08	PHASE3
NCT00610883	COMPLETED	Non-Hodgkin's Lymphoma	Memorial Sloan Kettering Cancer Center	1990-05	PHASE2
NCT00136435	COMPLETED	Acute Lymphoblastic Leukemia	Dana-Farber Cancer Institute	2002-06	PHASE2
NCT00176462	COMPLETED	Acute Lymphocytic Leukemia	Rutgers, The State University of New Jersey	2001-02	PHASE2
NCT00723346	COMPLETED	Acute Lymphoblastic Leukemia	ERYtech Pharma	2006-01	PHASE1; PHASE2
NCT00136084	COMPLETED	Leukemia, Myelocytic, Acute	St. Jude Children's Research Hospital	2002-08	PHASE3
NCT00003728	UNKNOWN	Leukemia; Lymphoma	European Organisation for Research and Treatment of Cancer - EORTC	1998-12	PHASE3
NCT00161239	TERMINATED	T-Cell Lymphoma	University of Medicine and Dentistry of New Jersey	2005-02
NCT00187057	COMPLETED	Ataxia-Telangiectasia	St. Jude Children's Research Hospital	2002-09
NCT01225874	COMPLETED	Leukemia	Children's Oncology Group	1999-12
NCT00526305	COMPLETED	Acute Lymphoblastic Leukemia	PETHEMA Foundation	2000-01	PHASE4
NCT00187122	COMPLETED	Lymphoblastic Lymphoma	St. Jude Children's Research Hospital	1993-03
NCT00187083	COMPLETED	Acute Lymphoblastic Leukemia	St. Jude Children's Research Hospital	1997-02	PHASE3
NCT00187005	TERMINATED	Acute Lymphoblastic Leukemia	St. Jude Children's Research Hospital	1998-07	PHASE3
NCT00002665	COMPLETED	Leukemia; Neutropenia; Thrombocytopenia	SWOG Cancer Research Network	1995-07	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-29)

Check the L-Asparaginase product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-Asparaginase functions as a deamidating enzyme that hydrolyzes circulatory L-asparagine and L-glutamine into aspartic acid and glutamic acid, thereby systematically depleting essential amino acids required for protein synthesis. This metabolic depletion selectively halts intracellular RNA and DNA synthesis, inducing apoptotic cell death in malignant lymphoblasts that lack endogenous asparagine synthetase, which provides the primary therapeutic basis for its efficacy in treating acute lymphoblastic leukemia and various lymphomas.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).