Randomized phase III GnG study on two schedules of gemtuzumab ozogamicin as adjunct to intensive induction therapy and double-blinded intensive postremission therapy with or without glasdegib in patients with newly diagnosed acute myeloid leukemia

Sonia Jaramillo; Johannes Krisam; Lucian Le Cornet; Markus Kratzmann; Lukas Baumann; Olga Eissymont; Martina Crysandt; Martin Görner; Sabine Kayser; Stefan Krause; Christoph Schliemann; Tobias Gaska; Martin Kaufmann; Jens Chemnitz; Markus Schaich; Alexander Hoellein; Uwe Platzbecker; Meinhard Kieser; Carsten Müller-Tidow; Richard F Schlenk

doi:10.3324/haematol.2023.284346

Randomized phase III GnG study on two schedules of gemtuzumab ozogamicin as adjunct to intensive induction therapy and double-blinded intensive postremission therapy with or without glasdegib in patients with newly diagnosed acute myeloid leukemia

Haematologica. 2024 Jun 1;109(6):1973-1976. doi: 10.3324/haematol.2023.284346.

Authors

Sonia Jaramillo¹, Johannes Krisam², Lucian Le Cornet³, Markus Kratzmann³, Lukas Baumann², Olga Eissymont², Martina Crysandt⁴, Martin Görner⁵, Sabine Kayser⁶, Stefan Krause⁷, Christoph Schliemann⁸, Tobias Gaska⁹, Martin Kaufmann¹⁰, Jens Chemnitz¹¹, Markus Schaich¹², Alexander Hoellein¹³, Uwe Platzbecker¹⁴, Meinhard Kieser², Carsten Müller-Tidow¹, Richard F Schlenk¹⁵

Affiliations

¹ Department of Internal Medicine V, Heidelberg University Hospital.
² Institute of Medical Biometry, University of Heidelberg.
³ NCT-Trial Center, National Center of Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center.
⁴ Department of Medicine IV, Aachen University Hospital, Aachen.
⁵ Department of Hematology, Oncology and Palliative Medicine, Community Hospital Bielefeld.
⁶ NCT-Trial Center, National Center of Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Germany; Institute of Transfusion Medicine and Immunology, Medical Faculty Mannheim, Heidelberg University; Department of Medicine I - Hematology and Cell Therapy, University Hospital Leipzig.
⁷ Department of Medicine V, Erlangen University Hospital.
⁸ Department of Medicine A, Münster University Hospital.
⁹ Department of Hematology and Oncology, St. Josef Brothers' Hospital Paderborn.
¹⁰ Department of Hematology, Oncology and Palliative Medicine, Robert-Bosch Hospital Stuttgart.
¹¹ Department of Internal Medicine, Hematology, Oncology and Palliative Medicine, Prot. Monastery Hospital St. Jakob Koblenz.
¹² Department of Hematology, Oncology and Palliative Medicine, Winnenden Hospital, Winnenden.
¹³ Department of Internal Medicine III - Hematology and Oncology, Red Cross Hospital Munich, Munich.
¹⁴ Department of Medicine I - Hematology and Cell Therapy, University Hospital Leipzig.
¹⁵ Department of Internal Medicine V, Heidelberg University Hospital, Germany; NCT-Trial Center, National Center of Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center.

No abstract available

Publication types

Clinical Trial, Phase III
Letter
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Aminoglycosides* / administration & dosage
Aminoglycosides* / therapeutic use
Antineoplastic Combined Chemotherapy Protocols* / adverse effects
Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
Benzimidazoles
Double-Blind Method
Female
Gemtuzumab* / administration & dosage
Gemtuzumab* / therapeutic use
Humans
Induction Chemotherapy
Leukemia, Myeloid, Acute* / diagnosis
Leukemia, Myeloid, Acute* / drug therapy
Male
Middle Aged
Phenylurea Compounds
Remission Induction
Treatment Outcome

Substances

Aminoglycosides
Benzimidazoles
Gemtuzumab
glasdegib
Phenylurea Compounds

Grants and funding

Funding: The trial was co-financed by funds of the German Research Organization (DFG- SCHL 2118/2-1). The study was supported by Pfizer Pharma GmbH.