- Trials with a EudraCT protocol (44)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
44 result(s) found for: Ozogamicin.
Displaying page 1 of 3.
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 | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: SE (Prematurely Ended) | |||||||||||||
Trial results: View results |
EudraCT Number: 2011-005491-41 | Sponsor Protocol Number: B1931022 | Start Date*: 2012-06-13 |
Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | ||
Full Title: An Open-label, Randomized Phase 3 Study of Inotuzumab Ozogamicin Compared to a Defined Investigator’s Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia... | ||
Medical condition: Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia | ||
Disease: | ||
Population Age: Adults, Elderly | Gender: Male, Female | |
Trial protocol: HU (Completed) CZ (Completed) SK (Completed) SE (Completed) ES (Completed) GB (Completed) DE (Completed) FI (Completed) IT (Completed) NL (Completed) BE (Completed) | ||
Trial results: View results |
EudraCT Number: 2008-007802-12 | Sponsor Protocol Number: 3129K5-2005-WW | Start Date*: 2009-07-23 | |||||||||||
Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc., A Pfizer Company | |||||||||||||
Full Title: An Open-label, Single-Arm, Phase 2 Study of Inotuzumab Ozogamicin Plus Rituximab in Subjects With Relapsed/Refractory CD22-Positive Diffuse Large B-Cell Lymphoma, Eligible for Autologous Stem Cell ... | |||||||||||||
Medical condition: Diffuse large B-cell Non-Hodgkin's lymphoma (DLBCL) | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Completed) FR (Completed) GB (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2007-000219-27 | Sponsor Protocol Number: 3129K4-3301-WW | Start Date*: 2008-04-25 | |||||||||||
Sponsor Name:Wyeth Pharmaceuticals Inc. acting through its division Wyeth Research, a Pfizer Company | |||||||||||||
Full Title: An Open-Label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin (CMC-544) Administered in Combination With Rituximab Compared to a Defined Investigator’s Choice Therapy in Subjects With Relapsed ... | |||||||||||||
Medical condition: Relapsed or refractory, CD22-Positive, follicular B-cell Non Hodgkin's Lymphoma | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: BE (Completed) ES (Completed) PT (Prematurely Ended) DE (Completed) FR (Completed) GB (Completed) IE (Completed) IT (Completed) | |||||||||||||
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: 2008-001635-34 | Sponsor Protocol Number: 3129K7-2001-WW | Start Date*: 2009-05-21 | |||||||||||
Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research & Development | |||||||||||||
Full Title: A Phase 2 Study of Inotuzumab Ozogamicin (CMC-544) in Subjects With Indolent Non-Hodgkin’s Lymphoma (NHL) That is Refractory to or has Relapsed After Rituximab and Chemotherapy or Radioimmunotherapy | |||||||||||||
Medical condition: Indolent Non-Hodgkin's Lymphoma | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: HU (Completed) DE (Prematurely Ended) BE (Completed) NL (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 | |||||||||||||
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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: 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: 2016-004836-39 | Sponsor Protocol Number: Initial-1 | Start Date*: 2017-11-01 | |||||||||||
Sponsor Name: Goethe Universität | |||||||||||||
Full Title: An open label phase II study to evaluate the efficacy and safety of Inotuzumab Ozogamicin for Induction Therapy followed by a conventional chemotherapy based consolidation and maintenance therapy I... | |||||||||||||
Medical condition: Acute lymphoblastic leukemia, Philadelphia-chromosome and BCR-ABL negative disease, patient aged 56 years or older | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Prematurely Ended) | |||||||||||||
Trial results: View results |
EudraCT Number: 2018-001557-27 | Sponsor Protocol Number: B1931030 | Start Date*: 2019-02-17 | |||||||||||
Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | |||||||||||||
Full Title: A PHASE 4, OPEN-LABEL, RANDOMIZED STUDY OF TWO INOTUZUMAB OZOGAMICIN DOSE LEVELS IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA ELIGIBLE FOR HEMATOPOIETIC STEM CE... | |||||||||||||
Medical condition: ADULT PATIENTS WITH RELAPSED OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA ELIGIBLE FOR HEMATOPOIETIC STEM CELL TRANSPLANTATION AND WHO HAVE RISK FACTOR(S) FOR VENO-OCCLUSIVE DISEASE | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: PL (Completed) BE (Completed) HU (Completed) ES (Ongoing) | |||||||||||||
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 | |||||||||||||||||||||||
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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: 2016-004942-27 | Sponsor Protocol Number: P16/11 | Start Date*: 2017-07-17 | |||||||||||
Sponsor Name:Centre Hospitalier de Versailles | |||||||||||||
Full Title: A Phase 2 Study of Inotuzumab Ozogamicin (INO) Combined to Chemotherapy in Older Patients with Philadelphia Chromosome-negative CD22+ B-cell Precursor Acute Lymphoblastic Leukemia | |||||||||||||
Medical condition: Philadelphia chromosome (Ph)-negative CD22+ B-cell Precursor (BCP) Acute Lymphoblastic Leukemia (ALL) | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: FR (Completed) FI (Completed) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2010-020147-12 | Sponsor Protocol Number: B1931008 | Start Date*: 2011-02-16 | |||||||||||
Sponsor Name:Pfizer Inc | |||||||||||||
Full Title: AN OPEN-LABEL, RANDOMIZED, PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN ADMINISTERED IN COMBINATION WITH RITUXIMAB COMPARED TO DEFINED INVESTIGATOR’S CHOICE THERAPY IN SUBJECTS WITH RELAPSED OR REFRACTOR... | |||||||||||||
Medical condition: Aggressive Non-Hodgkin Lymphoma (NHL) | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: CZ (Completed) SE (Completed) ES (Completed) DE (Completed) GB (Completed) HU (Completed) LT (Completed) BG (Completed) BE (Completed) GR (Completed) NL (Completed) SK (Completed) | |||||||||||||
Trial results: View results |
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. | |||||||||||||
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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: 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) | |||||||||||||
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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: 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... | |||||||||||||
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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... | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
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