- Trials with a EudraCT protocol (53)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (79)
53 result(s) found for: Asparaginase.
Displaying page 1 of 3.
EudraCT Number: 2016-004451-70 | Sponsor Protocol Number: NOR-GRASPALL-2016 | Start Date*: 2017-04-06 |
Sponsor Name:Department of pediatrics, Aarhus University Hospital | ||
Full Title: NOR-GRASPALL 2016: SINGLE-ARM PHARMACOKINETIC/PHARMACODYNAMIC AND SAFETY STUDY OF ERYASPASE (GRASPA®) FOR PATIENTS WITH HYPERSENSITIVITY TO PEG-ASPARAGINASE, DIAGNOSED WITH PH(-) ACUTE LYMPHOBLASTI... | ||
Medical condition: Patients with acute lymphoblastic leukemia with allergy against PEG-asparaginase | ||
Disease: | ||
Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults | Gender: Male, Female | |
Trial protocol: DK (Completed) NO (Completed) FI (Completed) SE (Completed) EE (Completed) LT (Completed) | ||
Trial results: View results |
EudraCT Number: 2005-000658-56 | Sponsor Protocol Number: 10/2-2005 | Start Date*: 2006-05-22 |
Sponsor Name:Deparment of pediatrics, Skejby Hospital, Denmark | ||
Full Title: PEG-asparaginase during two treatment courses in the treatment of childhood acute lymphoblastic leukemia (Användande av PEG-asparaginase under två behandlingsomgångar vid behandling av akut lymfati... | ||
Medical condition: Acute lymphoblastic leukemia in children. | ||
Disease: | ||
Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | |
Trial protocol: SE (Prematurely Ended) | ||
Trial results: (No results available) |
EudraCT Number: 2009-012584-34 | Sponsor Protocol Number: GRASPALL2009-06 | Start Date*: 2010-01-06 | |||||||||||
Sponsor Name:ERYTECH Pharma | |||||||||||||
Full Title: A multicentre, open, randomized, Phase II/III study, evaluating efficacy and safety of erythrocytes encapsulating L-Asparaginase (GRASPA®) versus reference L-asparaginase treatment in combination w... | |||||||||||||
Medical condition: Acute Lymphoblastic Leukaemia | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: BE (Completed) ES (Prematurely Ended) | |||||||||||||
Trial results: View results |
EudraCT Number: 2012-002026-78 | Sponsor Protocol Number: GRASPA-AML-2012-01 | Start Date*: 2014-02-26 | |||||||||||
Sponsor Name:ERYTECH Pharma | |||||||||||||
Full Title: A Multicentre, open, randomized, controlled phase IIb trial evaluating efficacy and tolerability of GRASPA (L-asparaginase encapsulated in red blood cells) plus low-dose cytarabine vs low-dose cyta... | |||||||||||||
Medical condition: Acute Myeloid Leukaemia | |||||||||||||
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Population Age: Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Completed) FI (Completed) DE (Completed) ES (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2010-020613-91 | Sponsor Protocol Number: MC-PEGASP.1/adults | Start Date*: 2010-11-18 | |||||||||||
Sponsor Name:medac Gesellschaft für klinische Spezialpräparate mbH | |||||||||||||
Full Title: A randomized, multi-centre, parallel-group, open label, Oncaspar® controlled dose ranging trial of three doses of pegylated recombinant asparaginase in adult patients with newly diagnosed acute lym... | |||||||||||||
Medical condition: Acute lymphoblastic leukaemia (ALL) is a clonal disease resulting from genetic mutations and transformation of a single early progenitor lymphoid cell. Uncontrolled expansion of leukaemic blasts in... | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2006-003180-31 | Sponsor Protocol Number: MC-ASP.5/ALL | Start Date*: 2008-07-29 | |||||||||||
Sponsor Name:medac GmbH | |||||||||||||
Full Title: Comparative efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukaemia | |||||||||||||
Medical condition: Acute lymphoblastic leukaemia (ALL) is a clonal disease resulting from genetic mutations and transformation of a single early progenitor lymphoid cell. Uncontrolled expansion of leukaemic blasts in... | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: NL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2013-004262-34 | Sponsor Protocol Number: GRASPANC2013-03 | Start Date*: 2014-02-24 | |||||||||||
Sponsor Name:ERYTECH Pharma | |||||||||||||
Full Title: Phase II, randomized, controlled, clinical trial exploring efficacy and safety of ERY001 (L-asparaginase encapsulated in Red Blood Cells) in association with gemcitabine or FOLFOX4 in second-line t... | |||||||||||||
Medical condition: Pancreatic cancer | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: FR (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2014-000328-47 | Sponsor Protocol Number: CV185-155 | Start Date*: 2015-09-15 | ||||||||||||||||
Sponsor Name:Bristol-Myers Squibb | ||||||||||||||||||
Full Title: A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention versus No Systemic Anticoagulant Prophylaxis during Induction Chemothera... | ||||||||||||||||||
Medical condition: Lymphoma, Acute Lymphoblastic Leukemia | ||||||||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | |||||||||||||||||
Trial protocol: Outside EU/EEA BE (Completed) PL (Completed) CZ (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2007-004021-19 | Sponsor Protocol Number: NOPHO ALL 2008 pilot | Start Date*: 2008-03-25 | |||||||||||
Sponsor Name:Rigshospitalet | |||||||||||||
Full Title: NOPHO ALL-2008 PILOT STUDY ON CONSOLIDATION THERAPY FOR CHILDREN AND YOUNG ADULTS WITH ACUTE LYMPHOBLASTIC LEUKAEMIA | |||||||||||||
Medical condition: Acute lymphoblastic leukemia in children 1.0-18 years of age | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: DK (Completed) SE (Completed) FI (Completed) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2014-003303-30 | Sponsor Protocol Number: 2014-003303-30 | Start Date*: 2015-05-22 | |||||||||||
Sponsor Name:Dutch Childhood Oncology Group | |||||||||||||
Full Title: TropicALL study; Thromboprophylaxis in Children treated for Acute Lymphoblastic Leukemia with Low-molecular-weight heparin: a randomized controlled trial | |||||||||||||
Medical condition: Acute lymphoblastic leukemia | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: NL (Prematurely Ended) | |||||||||||||
Trial results: View results |
EudraCT Number: 2022-002190-28 | Sponsor Protocol Number: SHP674-201\CL1-95014-001 | Start Date*: 2022-07-04 | |||||||||||
Sponsor Name:Institut de Recherches Internationales Servier (IRIS) | |||||||||||||
Full Title: A Phase 2 Clinical Study of SHP674 in Patients with Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia | |||||||||||||
Medical condition: Acute Lymphoblastic Leukemia | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2012-000793-30 | Sponsor Protocol Number: IntReALL-SR-2010 | Start Date*: 2013-10-25 | |||||||||||
Sponsor Name:Charité - University Hospital of Berlin | |||||||||||||
Full Title: International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 | |||||||||||||
Medical condition: Acute lymphoblastic leukemia (ALL) | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: SE (Completed) PT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) BE (Completed) AT (Completed) IE (Completed) FI (Completed) DK (Completed) CZ (Completed) IT (Completed) NL (Completed) FR (Completed) PL (Completed) ES (Prematurely Ended) NO (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2011-000908-18 | Sponsor Protocol Number: NOPHO-ALL2008 | Start Date*: 2011-06-29 | |||||||||||
Sponsor Name:Vilnius University Hospital Santariskiu Clinics | |||||||||||||
Full Title: Treatment Protocol for young adults (18-45 years of age) with Acute Lymphoblastic Leukemia | |||||||||||||
Medical condition: Acute lymphoblastic leukemia | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: LT (Prematurely Ended) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2012-000067-25 | Sponsor Protocol Number: ALL11 | Start Date*: 2012-10-19 | |||||||||||
Sponsor Name:Princess Máxima Center for pediatric oncology | |||||||||||||
Full Title: Protocol ALL-11: Treatment study protocol of the Dutch Childhood Oncology Group for children and adolescents (1-19 year) with newly diagnosed acute lymphoblastic leukemia | |||||||||||||
Medical condition: Acute lymphoblastic leukemia in children | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: NL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2020-004498-29 | Sponsor Protocol Number: 20190360 | Start Date*: 2022-01-13 | |||||||||||
Sponsor Name:Amgen Inc. | |||||||||||||
Full Title: Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor... | |||||||||||||
Medical condition: Newly Diagnosed Philadelphia (Ph)-negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL) | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Completed) PT (Trial now transitioned) SE (Trial now transitioned) AT (Trial now transitioned) FI (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) DK (Trial now transitioned) IT (Trial now transitioned) BE (Trial now transitioned) HU (Trial now transitioned) BG (Trial now transitioned) NL (Trial now transitioned) RO (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2018-003517-17 | Sponsor Protocol Number: ALL2518 | Start Date*: 2019-09-26 | |||||||||||
Sponsor Name:FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS | |||||||||||||
Full Title: Asparaginase Activity Monitoring (AAM) in adult patients with Acute Lymphoblastic Leukemia (ALL). | |||||||||||||
Medical condition: Adult patients, aged between 18 and 65, diagnosed with Acute Ph Lymphoblastic Leukemia negative (LAL Ph-) untreated, with a favorable impact on the prognosis. | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Prematurely Ended) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2008-006300-27 | Sponsor Protocol Number: MC-ASP.6/INF | Start Date*: 2009-08-12 | |||||||||||
Sponsor Name:medac Gesellschaft für klinische Spezialpräparate mbH | |||||||||||||
Full Title: Efficacy and safety of recombinant asparaginase in infants (< 1 year) with previously untreated acute lymphoblastic leukaemia - Phase II Clinical Trial - | |||||||||||||
Medical condition: Acute lymphoblastic leukaemia (ALL) is a clonal disease resulting from genetic mutations and transformation of a single early progenitor lymphoid cell. Uncontrolled expansion of leukaemic blasts in... | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: NL (Completed) DE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2014-000999-26 | Sponsor Protocol Number: 13-006 | Start Date*: 2014-09-20 | |||||||||||||||||||||
Sponsor Name:Jazz Pharmaceuticals, Inc. | |||||||||||||||||||||||
Full Title: An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (asparaginase Erwinia chrysanthemi)/Erwinase® (crisantaspase) Administered Following Hypersensitivity to E. c... | |||||||||||||||||||||||
Medical condition: 1) Acute Lymphoblastic Leukemia 2) Lymphoblastic Lymphoma | |||||||||||||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||||||||||||
Trial protocol: ES (Prematurely Ended) PL (Prematurely Ended) | |||||||||||||||||||||||
Trial results: View results |
EudraCT Number: 2018-002697-45 | Sponsor Protocol Number: ACT15378 | Start Date*: 2019-03-04 | ||||||||||||||||
Sponsor Name:Sanofi-aventis recherche & developpement | ||||||||||||||||||
Full Title: Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Year... | ||||||||||||||||||
Medical condition: Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination with Chemotherapy in Pediatric Patients from 28 Days to Less than 18 Year... | ||||||||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | |||||||||||||||||
Trial protocol: SE (Completed) NO (Completed) FI (Completed) DK (Completed) FR (Completed) NL (Completed) PT (Completed) BE (Completed) DE (Completed) CZ (Completed) GR (Completed) Outside EU/EEA IT (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2008-003235-20 | Sponsor Protocol Number: NOPHO-ALL-2008 | Start Date*: 2008-10-10 | |||||||||||
Sponsor Name:Rigshospitalet | |||||||||||||
Full Title: NOPHO-ALL-2008 Treatment Protocol for Children (1.0 - 17.9 years of age) with Acute Lymphoblastic Leukemia | |||||||||||||
Medical condition: Acute lymphoblastic leukemia | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: DK (Prematurely Ended) SE (Completed) FI (Completed) LT (Prematurely Ended) IS (Completed) | |||||||||||||
Trial results: (No results available) |
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