Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases (NCT05552469) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases
United States62 participantsStarted 2023-05-08
Plain-language 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 three 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), lower risk chronic myelomonocytic leukemia (LR CMML) and High-Risk Clonal Cytopenia of Undetermined Significance (HR CCUS).
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. In dose optimization: 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.
✓. changes for dose expansion (applicable as of amendment 3):
✓. LR MDS with ≤ 10% bone marrow blasts, IPSS-R score of ≤ 3.5, transfusion independent (TID) status as per IWG 2006 criteria (requiring \<4U pRBC in 8 weeks), clinically meaningful cytopenia(s) and no or limited (\<4 months) prior therapy for MDS.
✓. LR CMML patients with symptomatic cytopenias and/or constitutional symptoms refractory, intolerant or unsuitable for standard first-line therapy.
✓. HR-CCUS: Diagnosis of high-risk CCUS by clonal hematopoiesis risk score (CHRS) with clinically meaningful cytopenias and no prior therapy for a myeloid neoplasm.
Exclusion criteria
✕
What they're measuring
1
Incidence of Dose-limiting Toxicities (DLTs)
Timeframe: 28 days
2
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: 36 months
3
Incidence of dose interruptions, discontinuations and reductions