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

Summary

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.

Timeline

Start

2021-04-01

Primary completion

2022-06-15

Completion

2022-06-23

Publications

• Jaramillo S, Krisam J, Le Cornet L, Kratzmann M, Baumann L, Sauer T, Crysandt M, Rank A, Behringer D, Teichmann L, Gorner M, Trappe RU, Rollig C, Krause S, Hanoun M, Hopfer O, Held G, Buske S, Fransecky L, Kayser S, Schliemann C, Schaefer-Eckart K, Al-Fareh Y, Schubert J, Geer T, Kaufmann M, Brecht A, Niemann D, Kieser M, Bornhauser M, Platzbecker U, Serve H, Baldus CD, Muller-Tidow C, Schlenk RF. Rationale and design of the 2 by 2 factorial design GnG-trial: a randomized phase-III study to compare two schedules of gemtuzumab ozogamicin as adjunct to intensive induction therapy and to compare double-blinded intensive postremission therapy with or without glasdegib in older patients with newly diagnosed AML. Trials. 2021 Nov 3;22(1):765. doi: 10.1186/s13063-021-05703-w.

Drugs

Indications