MYLOTARG 5 mg powder for concentrate for solution for infusion

DRUG6 trials

Sponsors

Medical University Of Lodz, Centre Antoine Lacassagne, Prinses Maxima Centrum voor Kinderoncologie B.V., Fondazione Gimema Franco Mandelli Onlus, Technische Universitaet Dresden

Conditions

Acute Myeloid LeucaemiaAcute Myeloid LeukemiaFavorable-intermediate-risk Acute Myeloid LeukemiaNewly diagnosed acute myeloid leukaemia (AML)female and male adult patients with acute myeloid leukemiahigh risk myelodysplastic syndrome (MDS) and isolated myeloid sarcoma (either de novo or secondary)

Phase 1

AGORA-1 /ALFA 2100 study : A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults with FLT3-ITD and/or FLT3-TKD relapse/refractory (R/R) AML

Active, not recruitingCTIS2023-504176-25-00

Centre Antoine LacassagneAcute Myeloid Leukemia

Start: 2024-08-08Target: 50Updated: 2025-05-16

MidOStaurin + Gemtuzumab OzogAmIcin Combination in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)

RecruitingCTIS2024-514014-13-00

Technische Universitaet Dresdenfemale and male adult patients with acute myeloid leukemia

Start: 2020-09-02Target: 214Updated: 2025-12-15

Phase 3

CHIP-AML22 Master protocol: An open label complex clinical trial in newly diagnosed pediatric de novo AML patients – a study by the NOPHO-DB-SHIP consortium Master Protocol

RecruitingCTIS2023-504999-25-00

Prinses Maxima Centrum voor Kinderoncologie B.V.Acute Myeloid Leukemia

Start: 2023-07-14Target: 675Updated: 2025-08-14

MAGIC AML - Multiarm, Multicenter, RAndomized, Molecularly-GuIded Controlled Trial of Personalized Treatment Strategy - of Acute Myeloid Leukemia

RecruitingCTIS2023-503394-37-00

Medical University Of LodzAcute Myeloid Leucaemia

Start: 2024-10-23Target: 520Updated: 2025-10-15

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 Induction Chemotherapy

RecruitingCTIS2024-516112-21-00

The University Of Birminghamhigh risk myelodysplastic syndrome (MDS) and isolated myeloid sarcoma (either de novo or secondary), Newly diagnosed acute myeloid leukaemia (AML)

Start: 2017-11-20Target: 289Updated: 2024-12-02

Phase III study to assess the impact of gemtuzumab ozogamicin, in combination with standard chemotherapy, on the levels of minimal residual disease, in adult patients, aged 18-60 years, with previously untreated, de novo, favorable- intermediate-risk acute myeloid leukemia. AML1819

RecruitingCTIS2023-510433-29-00

Fondazione Gimema Franco Mandelli OnlusFavorable-intermediate-risk Acute Myeloid Leukemia

Start: 2020-09-24Target: 414Updated: 2025-01-10