Gemtuzumab ozogamicin plus midostaurin in combination with standard ‘7 + 3’ induction therapy in newly diagnosed AML: results from the SAL-MODULE phase I study
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...
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| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
June 2024
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| In: |
British journal of haematology
Year: 2024, Volume: 204, Issue: 6, Pages: 2254-2258 |
| ISSN: | 1365-2141 |
| DOI: | 10.1111/bjh.19436 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1111/bjh.19436 Verlag, lizenzpflichtig, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/bjh.19436 |
| Author Notes: | Christoph Röllig, Christoph Schliemann, Leo Ruhnke, Lars Fransecky, Björn-Niklas Heydrich, Maher Hanoun, Richard Noppeney, Kerstin Schäfer-Eckart, Knut Wendelin, Jan-Henrik Mikesch, Jan Moritz Middeke, Manja Reimann, Frank Fiebig, Sven Zukunft, Martin Wermke, Hubert Serve, Uwe Platzbecker, Carsten Müller-Tidow, Claudia D. Baldus, Martin Bornhäuser |
| Summary: | 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/m2 GO in combination with ‘7 + 3’ induction were evaluated. Based on safety findings in 12 patients, our results show that 3 mg/m2 GO on Days 1 + 4 and 100 mg midostaurin on Days 8-21 can be safely combined with IC in newly diagnosed AML. |
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| Item Description: | Veröffentlicht: 09 April 2024 Gesehen am 02.10.2024 |
| Physical Description: | Online Resource |
| ISSN: | 1365-2141 |
| DOI: | 10.1111/bjh.19436 |