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GO147: Induction therapy: Gemtuzumab Ozogamicin 3mg/m² on days 1,4 and 7

_G: Consolidation \& Maintenance therapy Glasdegib 100mg on days 4 to 27

GO147: Induction therapy: Gemtuzumab Ozogamicin 3mg/m² on days 1,4 and 7

_P: Consolidation \& Maintenance therapy Placebo 100mg on days 4 to 27

GO1: Induction therapy: Gemtuzumab Ozogamicin 3mg/m² on day 1

_G: Consolidation \& Maintenance therapy Glasdegib 100mg on days 4 to 27

GO1: Induction therapy: Gemtuzumab Ozogamicin 3mg/m² on day 1

_P: Consolidation \& Maintenance therapy Placebo 100mg on days 4 to 27

Induction therapy: Gemtuzumab Ozogamicin 3mg/m² on days 1,4 and 7

Gemtuzumab Ozogamicin 147

Induction therapy: Gemtuzumab Ozogamicin 3mg/m² on day 1

Gemtuzumab Ozogamicin 1

Consolidation \& Maintenance therapy Glasdegib 100mg on days 4 to 27

Glasdegib

Consolidation \& Maintenance therapy Placebo 100mg on days 4 to 27

Placebo Oral Tablet

The study is a randomized phase III trial with a 2x2 factorial design with measurable residual disease and event-free survival as primary endpoints, respectively. Patients are upfront randomized for the two induction schedules (Gemtuzumab Ozogamicin (GO)-147 versus GO-1; ratio 1:1) and for Glasdegib or Placebo (double blinded, ratio 1:1) as adjunct to consolidation therapy and as single agent 6 months maintenance therapy. Chemotherapy backbone for induction therapy is standard 7+3 with cytarabine 200mg/m² continuously day 1 to day 7, daunorubicin 60mg/m² days 1, 2 and 3 and for consolidation therapy intermediate dose cytarabine (1g/m², bi-daily, days 1,2,3). The trial is designed to gain evidence of anti-leukemic activity of GO and Glasdegib in older patients with newly diagnosed acute myeloid leukemia.

The two research questions are addressed in a 2 by 2 factorial design. Patients are upfront randomized for the two induction schedules (GO-147 versus GO-1, ratio 1:1) and for Glasdegib or Placebo (double blinded, ratio 1:1) as adjunct to consolidation therapy and as single agent 6 months maintenance therapy.

Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia)

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 Glasdegib in Older Patients With Newly Diagnosed AML

Minimal Residual Disease negativity (MRD-negativity) after induction therapy measured by flow cytometry.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia)	NCT04093505	Acute Myeloid L...	Gemtuzumab Ozog... Gemtuzumab Ozog... Glasdegib Placebo Oral Ta...	60 Years -	University Hospital Heidelberg
Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia)	NCT04093505	Acute Myeloid L...	Gemtuzumab Ozog... Gemtuzumab Ozog... Glasdegib Placebo Oral Ta...	60 Years -	University Hospital Heidelberg

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