Table 2.
Name | Phase | Patient population | Treatment | Comments |
---|---|---|---|---|
NCT00651261 | III | AML (FLT3-mutated) newly diagnosed age <60 years | Induction and consolidation chemotherapy ± midostaurin | First Phase III trial of midostaurin |
NCT01883362 | II | AML (FLT3-mutated) post-HCT | HCT followed by standard of care ± midostaurin 50 mg PO BID ×12 months | First trial of midostaurin maintenance after HCT |
NCT01477606 | II | AML (FLT3-mutated) | Midostaurin added to standard induction and consolidation therapy (including HCT) + maintenance midostaurin | First trial of midostaurin during induction, consolidation, and maintenance treatment of AML |
NCT00233454 | II | Aggressive systemic mastocytosis or mast cell leukemia | Midostaurin 100 mg PO BID | First trials of midostaurin in mastocytosis |
NCT00782067 | II | Aggressive systemic mastocytosis or mast cell leukemia ± an associated hematologic clonal non–mast cell lineage disease | Midostaurin 100 mg PO BID | |
NCT01920204 | II | Indolent or smoldering systemic mastocytosis with D816V mutation | Midostaurin 100 mg PO BID ×6 months | |
NCT00866281 | I/II | AML with FLT3 mutation (relapsed/refractory) or ALL with MLL rearrangement (relapsed/refractory) | Midostaurin PO BID (dose escalation) | First pediatric trial of midostaurin |
NCT01429337 | I | Healthy volunteers with normal or impaired hepatic function | Midostaurin 25 mg PO BID days 1–6, 25 mg PO daily on day 7 | First trial of midostaurin in patients with hepatic impairment Patients not required to have an underlying hematologic malignancy |
Abbreviations: AML, acute myeloid leukemia; ALL, acute lymphoblastic leukemia; PO, by mouth; BID, twice daily; HCT, hematopoietic cell transplant; FLT3, fms-like tyrosine kinase; MLL, mixed lineage leukemia.