Gemtuzumab ozogamicin plus midostaurin in combination with standard '7 + 3' induction therapy in newly diagnosed AML: Results from the SAL-MODULE phase I study.
Christoph RölligChristoph SchliemannLeo RuhnkeLars FranseckyBjörn-Niklas HeydrichMaher HanounRichard NoppeneyKerstin Schäfer-EckartKnut WendelinJan-Henrik MikeschJan Moritz MiddekeManja ReimannFrank FiebigSven ZukunftMartin WermkeHubert ServeUwe PlatzbeckerCarsten Müller-TidowClaudia D BaldusMartin BornhäuserPublished in: British journal of haematology (2024)
We conducted a phase I trial in newly diagnosed acute myeloid leukaemia (AML) to investigate the combination of two novel targeted agents, gemtuzumab ozogamicin (GO) and midostaurin, with intensive chemotherapy in FLT3-mutated AML and CBF leukaemia. Three dose levels of midostaurin and one to three sequential doses of 3 mg/m 2 GO in combination with '7 + 3' induction were evaluated. Based on safety findings in 12 patients, our results show that 3 mg/m 2 GO on Days 1 + 4 and 100 mg midostaurin on Days 8-21 can be safely combined with IC in newly diagnosed AML.
Keyphrases
- newly diagnosed
- acute myeloid leukemia
- allogeneic hematopoietic stem cell transplantation
- acute lymphoblastic leukemia
- liver failure
- clinical trial
- study protocol
- bone marrow
- randomized controlled trial
- dendritic cells
- cancer therapy
- intensive care unit
- phase iii
- drug delivery
- chronic kidney disease
- rectal cancer
- aortic dissection
- extracorporeal membrane oxygenation
- patient reported outcomes