Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases
Cancer-Related Syndrome
Leukemia
Myelodysplastic Syndromes (MDS)
18 Years and older, Male and Female
CDFV890G12101 (primary)
NCI-2023-01291
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.
Eligibility
- Patients must be = 18 years of age at the time of signing the informed consent form (ICF)
- The Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2
- Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institutions guidelines and must be willing to undergo a bone marrow aspirate.
- Patients must have one of the following for eligibility into the study:
- In dose optimization and expansion: IPSS-R defined very low, low or intermediate risk Myelodysplastic Syndrome (LR MDS) who failed to respond to or did not tolerate ESAs or luspatercept or HMAs and patients with del 5q who failed to respond to or did not tolerate lenalidomide; or
- In dose optimization and expansion: IPSS-R defined very low, low or intermediate risk Chronic Myelomonocytic Leukemia (LR CMML) who failed to respond to or did not tolerate hydroxyurea or HMAs. Key
Treatment Sites in Georgia
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