biostudies-literatureJaramillo SUniversitätsklinikum HeidelbergGerman Research Organization765https://www.ebi.ac.uk/biostudies/studies/S-EPMC8564967biostudies-literatureUnknown22(1)<h4>Background</h4>Overall survival remains poor in older patients with acute myeloid leukemia (AML) with less than 10% being alive after 5 years. In recent studies, a significant improvement in event-free, relapse-free and overall survival was shown by adding gemtuzumab ozogamicin (GO), a humanized antibody-drug conjugate directed against CD33, to intensive induction therapy once or in a sequential dosing schedule. Glasdegib, the small-molecule inhibitor of smoothened (SMO), also showed improved overall survival in patients not eligible for intensive chemotherapy when combined with low-dose cytarabine compared to low-dose cytarabine alone. These findings warrant further investigations in the phase III GnG trial.<h4>Methods/design</h4>This is a randomized phase III trial with measurable reTrialsRationale 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.PMC8564967DFG- SCHL 2118/2-1Kieser MCrysandt MKayser SBaumann LBaldus CDTrappe RUJaramillo SGorner MSchubert JAl-Fareh YMuller-Tidow CRank ASchlenk RFTeichmann LHeld GSchaefer-Eckart KSauer TPlatzbecker UBuske SBehringer DKrisam JFransecky LKaufmann MBrecht AKrause SServe HHopfer OBornhauser MKratzmann MNiemann DHanoun MGeer TRollig CSchliemann CLe Cornet LfalseRationale 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.<h4>Background</h4>Overall survival remains poor in older patients with acute myeloid leukemia (AML) with less than 10% being alive after 5 years. In recent studies, a significant improvement in event-free, relapse-free and overall survival was shown by adding gemtuzumab ozogamicin (GO), a humanized antibody-drug conjugate directed against CD33, to intensive induction therapy once or in a sequential dosing schedule. Glasdegib, the small-molecule inhibitor of smoothened (SMO), also showed improved overall survival in patients not eligible for intensive chemotherapy when combined with low-dose cytarabine compared to low-dose cytarabine alone. These findings warrant further investigations in the phase III GnG trial.<h4>Methods/design</h4>This is a randomized phase III trial with measurable re2021-01-01T00:00:00Z2021 Nov2026-05-08T05:22:28.518Z2026-05-01T03:05:55.07ZS-EPMC85649673473223610.1186/s13063-021-05703-w