Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases
Running, not enrolling · Phase 1
Conditions studied: Myeloid Diseases
In brief
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).
Key facts
- Study ID
- NCT05552469
- Run by
- Novartis Pharmaceuticals
- People needed
- 62
- Starts
- 2023-05-08
- Expected to finish
- 2027-01-13
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Stanford Cancer Center — Stanford, California, United States
- H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
- Northwestern University — Chicago, Illinois, United States
- Sidney Kimmel CCC At JH — Baltimore, Maryland, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Mayo Clinic Rochester — Rochester, Minnesota, United States
- Weill Cornell Medicine NY-Presb — New York, New York, United States
- Memorial Sloan Kettering Cancer Ctr — New York, New York, United States
- Vanderbilt University Medical Ctr — Nashville, Tennessee, United States
- Univ of TX MD Anderson Cancer Cntr — Houston, Texas, United States
- Huntsman Cancer Institute — Salt Lake City, Utah, United States
- Novartis Investigative Site — Grenoble, France
- Novartis Investigative Site — Nantes, France
- Novartis Investigative Site — Paris, France
- Novartis Investigative Site — Düsseldorf, North Rhine-Westphalia, Germany
- Novartis Investigative Site — Dresden, Saxony, Germany
- Novartis Investigative Site — Leipzig, Saxony, Germany
- Novartis Investigative Site — Lübeck, Germany
- Novartis Investigative Site — Hong Kong, Hong Kong
- Novartis Investigative Site — Brescia, BS, Italy
- Novartis Investigative Site — Rozzano, MI, Italy
- Novartis Investigative Site — Singapore, Singapore
- Novartis Investigative Site — Madrid, Spain
- Novartis Investigative Site — Cardiff, United Kingdom
- Novartis Investigative Site — London, United Kingdom
Full record on ClinicalTrials.gov
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