Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases

Active:	Yes
Cancer Type:	Cancer-Related Syndrome Leukemia Myelodysplastic Syndromes (MDS)	NCT ID:	NCT05552469
Trial Phases:	Phase I	Protocol IDs:	CDFV890G12101 (primary) NCI-2023-01291
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Novartis Pharmaceuticals Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT05552469

Summary

Study CDFV890G12101 is an open-label, phase 1b, multicenter study with a randomized
two-dose optimization part, and a dose expansion part consisting of two groups evaluating
DFV890 in patients with myeloid diseases. The purpose of this study is to assess the
safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy and recommended dose
for single agent DFV890 in patients with lower risk (LR: very low, low or intermediate
risk) myelodysplastic syndromes (LR MDS) and lower risk chronic myelomonocytic leukemia
(LR CMML).

Objectives

This research study is to find out if study treatment DFV890 is safe and tolerable, and
can help patients who were diagnosed with a myeloid disease such as: very low, low or
intermediate risk myelodysplastic syndromes (MDS) and very low, low or intermediate risk
chronic myelomonocytic leukemia (CMML). The study seeks to determine the optimal dose of
DFV890 that is safe and efficacious in patients with myeloid disease. The effectiveness
and safety/tolerability of the study treatment is not yet confirmed in this disease
setting.

Eligible patients meeting all study entry requirements will be required to provide a
sample from their bone marrow at screening and at select study timepoints. All enrolled
patients will be dosed for a minimum of twenty-four weeks (6 cycles of treatment) unless
they experience side effects related to the study treatment requiring dose
interruption/discontinuation, worsening of the disease, and/or if treatment is
discontinued at the discretion of the investigator or the patient.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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