Study #2019-1246
A Phase 1/2a, Open-Label Dose Escalation and Cohort Expansion Study of Orally Administered CA-4948 (IRAK4i) as a Monotherapy in Patients with Acute Myelogenous Leukemia orMyelodysplastic Syndrome and in Combination with Azacitidine or Venetoclax.
MD Anderson Study Status
Enrolling
Treatment Agent
Emavusertib, Azacitidine, Venetoclax
Description
This is a multicenter, open-label, Phase 1/2a dose escalation and expansion study of orally administered emavusertib (CA-4948) monotherapy and in combination with azacitidine or venetoclax in adult patients with Acute Myelogenous Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS). - R/R AML, FLT3-ITD mutant AML patients after failing at least 1 to 3 pretreatments, including a FLT3 inhibitor - R/R AML with FLT3 WT, after failing 1 to 3 pretreatments. Desired enrichment for expression of spliceosome mutations - R/R hrMDS with spliceosome mutations (SF3B1, U2AF1, SRSF2, ZRSR2), resistant/refractory to HMA; ineligible for intensive chemotherapy; maximal 3 pretreatments - R/R hrMDS without spliceosome mutations; resistant/refractory to r/r to HMA; ineligible for intensive chemotherapy; maximal 3 pretreatments
Information and next steps
Disease:
Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Study phase:
I/II
Physician name:
Guillermo Garcia-Manero
Department:
Leukemia
For general questions about clinical trials:
1-877-632-6789
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