Leukemia, Myeloid, Acute Clinical Trial
Official title:
A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP-5336 in Adult Acute Leukemia Patients With and Without Mixed Lineage Leukemia (MLL)-Rearrangement or Nucleophosmin 1 (NPM1) Mutation
A Phase 1/2 dose escalation / dose expansion study of DSP 5336 in patients with relapsed or refractory AML.
Phase 1 (dose escalation) will determine the recommended Phase 2 dose (RP2D) (i.e. the lowest dose of DSP 5336, that provides the maximum biologic and clinical effect, or the MTD, whichever is lower) in adult patients with relapsed or refractory AML, ALL, or acute leukemia of ambiguous lineage. Enrollment to the phase 1 portion of the study may be limited to patients with certain genetic abnormalities. Phase 2 dose-expansion will further evaluate the safety and clinical activity of DSP 5336 in adult patients with relapsed or refractory MLLr AML or NPM1m AML. ;
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