{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Jaramillo S"],"funding":["Universitätsklinikum Heidelberg","German Research Organization"],"pagination":["765"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8564967"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["22(1)"],"pubmed_abstract":["<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 re"],"journal":["Trials"],"pubmed_title":["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."],"pmcid":["PMC8564967"],"funding_grant_id":["DFG- SCHL 2118/2-1"],"pubmed_authors":["Kieser M","Crysandt M","Kayser S","Baumann L","Baldus CD","Trappe RU","Jaramillo S","Gorner M","Schubert J","Al-Fareh Y","Muller-Tidow C","Rank A","Schlenk RF","Teichmann L","Held G","Schaefer-Eckart K","Sauer T","Platzbecker U","Buske S","Behringer D","Krisam J","Fransecky L","Kaufmann M","Brecht A","Krause S","Serve H","Hopfer O","Bornhauser M","Kratzmann M","Niemann D","Hanoun M","Geer T","Rollig C","Schliemann C","Le Cornet L"],"additional_accession":[]},"is_claimable":false,"name":"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.","description":"<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 re","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Nov","modification":"2026-05-08T05:22:28.518Z","creation":"2026-05-01T03:05:55.07Z"},"accession":"S-EPMC8564967","cross_references":{"pubmed":["34732236"],"doi":["10.1186/s13063-021-05703-w"]}}