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Clinical trials for Gemtuzumab ozogamicin

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    The EU Clinical Trials Register currently displays   44341   clinical trials with a EudraCT protocol, of which   7370   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).

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    31 result(s) found for: Gemtuzumab ozogamicin. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2016-001533-28 Sponsor Protocol Number: AAML0531 Start Date*: 2016-05-03
    Sponsor Name:Children's Oncology Group
    Full Title: A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults
    Medical condition: Acute myeloid leukaemia
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-002743-89 Sponsor Protocol Number: S0106 Start Date*: 2007-04-10
    Sponsor Name:Southwest Oncology Group (SWOG)
    Full Title: A PHASE III STUDY OF THE ADDITION OF GEMTUZUMAB OZOGAMICIN (MYLOTARG®) DURING INDUCTION THERAPY VERSUS STANDARD INDUCTION WITH DAUNOMYCIN AND CYTOSINE ARABINOSIDE FOLLOWED BY CONSOLIDATION AND SUBS...
    Medical condition: Previously untreated de novo acute myeloid leukemia
    Disease: Version SOC Term Classification Code Term Level
    8.1 10000886 Acute myeloid leukemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-011889-28 Sponsor Protocol Number: AMLSG09-09 Start Date*: 2010-02-08
    Sponsor Name:University of Ulm
    Full Title: Phase III study of chemotherapy in combination with ATRA with or without gemtuzumab ozogamicin in patients with acute myeloid leukemia and NPM1 gene mutation
    Medical condition: adult patients with AML and NPM1 mutation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2004-003739-30 Sponsor Protocol Number: AMLSG 05-04 Start Date*: 2005-11-02
    Sponsor Name:Universitätsklinikum Ulm / University Clinical Center Ulm
    Full Title: Phase II Study on Gemtuzumab Ozogamicin in Combination with All-trans-Retinoic Acid, high-dose Cytarabine and Mitoxantrone in Patients with primary refractory acute myeloid leukemia [GO-A-HAM]
    Medical condition: primary refractory patients with acute myeloid leukemia
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2020-002428-36 Sponsor Protocol Number: RG_19-271 Start Date*: 2020-12-02
    Sponsor Name:University of Birmingham
    Full Title: A phase II trial to assess the activity of Gemtuzumab Ozogamicin Therapy in Haemophagocytic lymphohistiocytosis (HLH) or Macrophage activation syndrome (MAS) or relapsed/refractory solid tumours
    Medical condition: Haemophagocytic lymphohistiocytosis (HLH) or Macrophage activation syndrome (MAS) and relapsed/refractory solid tumours
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021428 - Immune system disorders 10071583 Haemophagocytic lymphohistiocytosis PT
    21.1 10021428 - Immune system disorders 10053867 Macrophage activation syndrome LLT
    20.0 100000004864 10007050 Cancer LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2014-005066-30 Sponsor Protocol Number: RG_14-088 Start Date*: 2018-03-20
    Sponsor Name:The University of Birmingham
    Full Title: MyeChild 01: International Randomised Phase III Clinical Trial in Children with Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination with ...
    Medical condition: Newly diagnosed acute myeloid leukaemia (AML), high risk myelodysplastic syndrome(MDS) and isolated myeloid sarcoma (either de novo or secondary) are eligible for the trial.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IE (Trial now transitioned) GB (GB - no longer in EU/EEA) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003913-32 Sponsor Protocol Number: HeLeNe-18-02 Start Date*: 2020-11-18
    Sponsor Name:Ruprecht-Karls-University of Heidelberg Medical Faculty represented in law by Heidelberg University Hospital
    Full Title: Randomized phase-III study to compare two schedules of gemtuzumab ozogamicin as adjunct to intensive induction therapy and to compare intensive postremission therapy double blinded with or without ...
    Medical condition: acute myeloid leukemia (AML)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-002933-36 Sponsor Protocol Number: ALFA-0701 Study (Mylofrance 3) Start Date*: 2007-11-02
    Sponsor Name:CH-Versailles
    Full Title: Etude de phase 3 randomisée multicentrique étudiant l’effet de l’addition de l’anticorps monoclonal Gemtuzumab Ozogamicin (Mylotarg) utilisé en doses fractionnées au traitement d’induction et de co...
    Medical condition: The standard regimen for AML is the with Mylotarg, 3 mg/m2 given on days 1,4 and 7.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003212-11 Sponsor Protocol Number: ITCC-101/APAL2020D Start Date*: 2022-02-17
    Sponsor Name:Princess Máxima Center
    Full Title: A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML
    Medical condition: Children, adolescents, and young adults up to the age of 21 years with acute myeloid leukemia with a documented negative test for FLT3/ITD mutation and either: - Untreated second relapse, who are s...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001941 AML LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned) AT (Trial now transitioned) SE (Trial now transitioned) IE (Trial now transitioned) NO (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned) FI (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003863-23 Sponsor Protocol Number: TUD-MOSAIC-075 Start Date*: 2020-07-03
    Sponsor Name:Technische Universität Dresden
    Full Title: Midostaurin + Gemtuzumab Ozogamicin combination in first-line standard therapy for acute myeloid leukemia
    Medical condition: Patients with newly diagnosed acute myeloid leukemia (AML) fit for intensive curative treatment displaying a cytogenetic aberration or fusion transcript in the core-binding factor (CBF) genes or FL...
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2004-001918-13 Sponsor Protocol Number: Hovon 43 Start Date*: 2008-01-17
    Sponsor Name:University of Wales College of Medicine
    Full Title: Randomised induction and post induction therapy in older patients (>=61 years of age) with acute myeloid leukaemia (AML) and refractory anaemia with excess blasts (RAEB, RAEB-t)
    Medical condition: Acute Myeloid Leukaemia (AML) Refractory Anaemia with Excesss Blasts (RAEB)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2017-005158-12 Sponsor Protocol Number: NCT-2017-0530 Start Date*: 2019-04-01
    Sponsor Name: Ruprecht-Karls-University Heidelberg Medical Faculty, University Hospital
    Full Title: TEAM-Trial: Targeting Epigenetic therapy resistance in AML with Bortezomib: A multi-centre matched threshold crossing phase II approach
    Medical condition: Patients with confirmed diagnosis of Acute Myeloid Leukemia (AML)according to WHO-2016 classification (except acute promyelocytic leukemia) either de novo AML, AML after preceding myelodysplastic o...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-000227-71 Sponsor Protocol Number: ITCC-059 Start Date*: 2016-09-02
    Sponsor Name:Erasmus Medical Center
    Full Title: A phase I/II study of Inotuzumab Ozogamicin as a single agent and in combination with chemotherapy for pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia
    Medical condition: pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) DE (Trial now transitioned) IE (Trial now transitioned) AT (Trial now transitioned) SE (Trial now transitioned) DK (Trial now transitioned) ES (Ongoing) CZ (Ongoing) GB (GB - no longer in EU/EEA) FR (Trial now transitioned) IT (Trial now transitioned) NO (Trial now transitioned) FI (Trial now transitioned) PT (Prematurely Ended) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003871-20 Sponsor Protocol Number: AML1819 Start Date*: 2020-02-26
    Sponsor Name:FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
    Full Title: Phase III study to assess the impact of gemtuzumab ozogamicin, in combination with standard chemotherapy, on the levels of minimal residual disease, and the role of glasdegib as a post-transplant m...
    Medical condition: Favorable-intermediate-risk Acute Myeloid Leukemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-002619-89 Sponsor Protocol Number: B1761031 Start Date*: 2019-06-05
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A SINGLE ARM, OPEN-LABEL, PHASE 4 STUDY EVALUATING QT INTERVAL, PHARMACOKINETICS, AND SAFETY OF GEMTUZUMAB OZOGAMICIN (MYLOTARG™) AS A SINGLE-AGENT REGIMEN IN PATIENTS WITH RELAPSED OR REFRACTOR...
    Medical condition: relapsed or refractory CD33-positive acute myeloid leukaemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) HU (Completed) PL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2004-004356-39 Sponsor Protocol Number: GIMEMAAML19(EORTC06031) Start Date*: 2005-05-16
    Sponsor Name:E.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER
    Full Title: Gemtuzumab Ozogamicin (GO) monotherapy versus standard supportive care for previously untreated AML in elderly patients who are not eligible for intensive chemotherapy: a randomized phase II/III tr...
    Medical condition: Elderly patients (61-75 years not eligible for intensive chemotherapy;age > 75 years), with previously untreated, primary or secondary (no after other myeloproliferative diseases) AML (except M3).
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002383-40 Sponsor Protocol Number: ICC_APL_Study_02 Start Date*: 2019-03-20
    Sponsor Name:AIEOP- Associazione Italiana Ematologia Oncologia Pediatrica
    Full Title: Treatment study for children and adolescents with Acute Promyelocytic Leukemia
    Medical condition: acute promyelocytic leukemia (APL) in children and adolescents
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) FR (Trial now transitioned) SE (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-018980-41 Sponsor Protocol Number: Pediatric_Relapsed_AML2010/01 Start Date*: 2013-10-15
    Sponsor Name:German Society of Pediatric Hematology and Oncology gGmbH (GPOH gGmbH)
    Full Title: International randomized phase III study on the treatment of children and adolescents with refractory or relapsed acute myeloid leukemia
    Medical condition: Pediatric relapsed or refractory AML
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) HU (Completed) DK (Prematurely Ended) CZ (Prematurely Ended) NL (Ongoing) SE (Prematurely Ended) IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001684-89 Sponsor Protocol Number: RG_20-030 Start Date*: 2020-05-05
    Sponsor Name:University of Birmingham
    Full Title: CATALYST - A randomised phase II proof of principle multi-arm multi-stage trial designed to guide the selection of interventions for phase III trials in hospitalised patients with COVID-19 infection.
    Medical condition: COVID-19
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004855 10047468 Viral lower respiratory tract infections HLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-001321-68 Sponsor Protocol Number: B1761026 Start Date*: 2018-05-22
    Sponsor Name:Pfizer, Inc.
    Full Title: Gemtuzumab Ozogamicin (mylotarg (registered)) Expanded Access Protocol For Treatment Of Patients In The United States With Relapsed/refractory Acute Myelogenous Leukemia Who May Benefit From Treatm...
    Medical condition: Acute Myelogenous Leukemia, including myelodysplastic syndrome and acute promyelocytic leukemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
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