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Clinical Trial
. 2024 Jun;204(6):2254-2258.
doi: 10.1111/bjh.19436. Epub 2024 Apr 9.

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 Röllig  1 , Christoph Schliemann  2 , Leo Ruhnke  1 , Lars Fransecky  3 , Björn-Niklas Heydrich  3 , Maher Hanoun  4 , Richard Noppeney  4 , Kerstin Schäfer-Eckart  5 , Knut Wendelin  5 , Jan-Henrik Mikesch  2 , Jan Moritz Middeke  1 , Manja Reimann  1 , Frank Fiebig  1 , Sven Zukunft  1 , Martin Wermke  1 , Hubert Serve  6 , Uwe Platzbecker  7 , Carsten Müller-Tidow  8 , Claudia D Baldus  3 , Martin Bornhäuser  1   9
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Clinical Trial

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 Röllig et al. Br J Haematol. 2024 Jun.

Abstract

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.

Keywords: AML; gemtuzumab ozogamicin; induction therapy; intensive therapy; midostaurin.

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References

REFERENCES

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