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Clinical trials for Pegaspargase

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    25 result(s) found for: Pegaspargase. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2020-004894-29 Sponsor Protocol Number: CL2-95014-002 Start Date*: 2021-09-17
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: A multicentre, Phase II Randomized study, Open-label, with 2-arm Parallel Group, comparing the pharmacokinetics of the Liquid and the Lyophilized Formulations of pegaspargase (S95014) in Treatment ...
    Medical condition: Newly diagnosed paediatric patients with Acute Lymphoblastic Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-004895-17 Sponsor Protocol Number: CL2-95014-003 Start Date*: 2021-09-17
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: A multicentre, roll-over study to provide continued treatment with lyophilized pegaspargase (S95014) in Pediatric Patients with Acute Lymphoblastic Leukemia (ALL)
    Medical condition: Continued treatment with lyophilized pegaspargase in paediatrics patients with Acute Lymphoblastic Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-001738-17 Sponsor Protocol Number: GIMEMALAL0904 Start Date*: 2004-11-08
    Sponsor Name:G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
    Full Title: Evaluation of the intensification of post-remissional therapy in the treatment of high-risks adult Acute Lymphoblastic Leukemia and monitoring of the minimal residual disease
    Medical condition: Patients with T- and B-ALL; Age >14 and <61 years
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000846 Acute lymphocytic leukaemia PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    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
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-002476-92 Sponsor Protocol Number: 20120215 Start Date*: 2015-06-29
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Open-label, Controlled Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidatio...
    Medical condition: Patients with Philadelphia chromosome negative (Ph-) high-risk (HR) first relapse B-precursor ALL (as defined by I-BFM SG/IntReALL criteria)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    21.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    21.1 100000004864 10066109 Precursor B-lymphoblastic leukemia acute LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) BE (Completed) IT (Completed) SE (Completed) PT (Completed) DK (Completed) AT (Completed) GB (GB - no longer in EU/EEA) PL (Completed) ES (Ongoing) FR (Completed) NL (Completed) Outside EU/EEA GR (Completed) NO (Completed) HU (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2017-001691-39 Sponsor Protocol Number: UKM17_0023 Start Date*: 2019-07-16
    Sponsor Name:University Hospital Münster
    Full Title: LBL 2018 - International cooperative treatment protocol for children and adolescents with lymphoblastic lymphoma
    Medical condition: Lymphoblastic lymphoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10065923 Lymphoblastic lymphoma LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) DE (Ongoing) DK (Trial now transitioned) IE (Completed) NO (Trial now transitioned) FI (Trial now transitioned) AT (Trial now transitioned) CZ (Trial now transitioned) SE (Trial now transitioned) ES (Ongoing) NL (Ongoing) SK (Trial now transitioned) HU (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-002734-41 Sponsor Protocol Number: P091205 Start Date*: Information not available in EudraCT
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000186-40 Sponsor Protocol Number: B1931036 Start Date*: 2022-10-07
    Sponsor Name:Pfizer Inc.
    Full Title: A PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH RISK FIRST RELAPSE B-CELL...
    Medical condition: Acute Lymphoblastic Leukemia (ALL)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) DE (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) SE (Trial now transitioned) NO (Trial now transitioned) FR (Trial now transitioned) SK (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) GR (Trial now transitioned) CZ (Ongoing) NL (Trial now transitioned) FI (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
    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)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000844 Acute lymphoblastic leukaemia LLT
    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: 2017-000705-20 Sponsor Protocol Number: EsPhALL2017/COGAALL1631 Start Date*: 2017-12-11
    Sponsor Name:Università degli Studi Milano Bicocca
    Full Title: International phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones
    Medical condition: Philadelphia positive Acute Lumphoblastic Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 10022891 - Investigations 10034877 Philadelphia chromosome positive PT
    21.0 100000004864 10000844 Acute lymphoblastic leukaemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Ongoing) IT (Trial now transitioned) NL (Trial now transitioned) CZ (Trial now transitioned) DE (Trial now transitioned) FI (Trial now transitioned) BE (Trial now transitioned) SE (Trial now transitioned) PL (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
    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
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    17.0 100000004851 10036544 Precursor T-lymphoblastic lymphomas/leukaemias HLT
    17.0 100000004851 10036524 Precursor B-lymphoblastic lymphomas HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-020924-22 Sponsor Protocol Number: RG_09-072 Start Date*: 2011-12-02
    Sponsor Name:University of Birmingham
    Full Title: United Kingdom National Randomised Trial for Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoma 2011
    Medical condition: Acute lymphoblastic leukaemia and lymphoblastic lymphoma
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004864 10000845 Acute lymphoblastic leukemia LLT
    18.1 100000004864 10065923 Lymphoblastic lymphoma LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-016075-30 Sponsor Protocol Number: GIMEMA LAL1308 Start Date*: 2010-07-09
    Sponsor Name:G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL`ADULTO
    Full Title: Therapy of the Young Adult Acute Lymphoblastic Leukemia (ALL): treatment intensification of the pediatric protocol AIEOP LLA-2000
    Medical condition: Acute Lymphoblastic Leukemia (ALL)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10000844 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    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...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000844 Acute lymphoblastic leukaemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-003466-13 Sponsor Protocol Number: GMALL082013 Start Date*: 2015-09-15
    Sponsor Name:Goethe University Frankfurt
    Full Title: Treatment optimization in adult patients with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma by individualised, targeted and intensified treatment - a phase IV-trial with a ...
    Medical condition: Newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma Age 18 to 55 y
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000845 Acute lymphoblastic leukemia LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065923 Lymphoblastic lymphoma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-004270-43 Sponsor Protocol Number: AIEOP-BFMALL2009 Start Date*: Information not available in EudraCT
    Sponsor Name:Universitätsklinikum Schleswig-Holstein, Campus Kiel
    Full Title: International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia
    Medical condition: acute lymphoblastic leukemia in children and adolescents 1 to <18 years of age
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) AT (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-000760-21 Sponsor Protocol Number: GMALL-EVOLVE Start Date*: 2023-03-28
    Sponsor Name:Goethe-University
    Full Title: A multicentre, randomized trial in adults with de novo Philadelphia-Chromosome positive acute lymphoblastic leukemia to assess the efficacy of ponatinib versus imatinib in combination with low-inte...
    Medical condition: De novo Philadelphia-Chromosome positive acute lymphoblastic leukemia (Ph+ALL)
    Disease: Version SOC Term Classification Code Term Level
    24.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10080018 Philadelphia positive acute lymphocytic leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-012758-18 Sponsor Protocol Number: COALL09-05-04 Start Date*: 2010-09-09
    Sponsor Name:Universitätsklinikum Hamburg-Eppendorf
    Full Title: A randomized multi-center treatment study (COALL 08-09) to improve the survival of children with acute lymphoblastic leukemia on behalf of the German Society of Pediatric Hematology and Oncology
    Medical condition: acute lymphoblastic leukemia in children and adolescents 1 to ≤ 18 years of age
    Disease: Version SOC Term Classification Code Term Level
    12.1 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005019-29 Sponsor Protocol Number: Rux-cALL-Pol_2020 Start Date*: Information not available in EudraCT
    Sponsor Name:Medical University of Lodz
    Full Title: Single-arm interventional study with ruxolitinib and AIOEP-BFM2017 chemotherapy in children with acute lymphoblastic leukemia and confirmed activation of JAK/STAT pathway.
    Medical condition: Acute Lymphoblastic Leukemia with confirmed activating of JAK/STAT pathway in children and adolescents <18 years of age
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    22.0 100000004850 10072213 JAK-2 mutation LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-001935-12 Sponsor Protocol Number: AIEOP-BFM-ALL-2017 Start Date*: 2018-07-02
    Sponsor Name:Universitätsklinikum Schleswig-Holstein, Campus Kiel
    Full Title: AIEOP-BFM ALL 2017 - International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia
    Medical condition: acute lymphoblastic leukemia in children and adolescents <18 years of age
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned) IT (Trial now transitioned) SK (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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