IMLEU22035 / CA-4948-102 / Liesveld
Basic Study Information
Purpose:Location: University of Rochester Medical Center
This is a multicenter, open-label, Phase 1/2a dose escalation and expansion study
of orally administered emavusertib (CA-4948) monotherapy in adult patients with Acute
Myelogenous Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS).
Patients enrolling in the Phase 1 portion of the study must meet one of the following
criteria prior to consenting to the study:
R/R AML with FLT3 mutations who have been previously treated with a FLT3 inhibitor
R/R AML with spliceosome mutations of SF3B1 or U2AF1
R/R hrMDS with spliceosome mutations of SF3B1 or U2AF1
Number of pretreatments: 1 or 2
The Phase 2a Dose Expansion will be in 3 Cohorts of patients:
R/R AML with FLT3 mutations who have been previously treated with a FLT3 inhibitor;
R/R AML with spliceosome mutations of SF3B1 or U2AF1; and
R/R hrMDS (IPSS-R score > 3.5) with spliceosome mutations of SF3B1 or U2AF1.
All patients above have had ≤ 2 lines of prior systemic anticancer treatment. In previous
versions of this protocol there was a Phase 1b portion of the study, in which patients
with AML or hrMDS received CA-4948 in combination with venetoclax. This part of the
study is no longer open for enrollment.
Lead Researcher (Principal Investigator)
Jane Liesveld, MD
Study Contact Information
Study Contact: Clinical Trials Office
Study Location: Wilmot Cancer Institute, University of Rochester Medical Center
Study Email: WCICTOResearch@urmc.rochester.edu
Additional Study Details
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