ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1b, Open Label, Multi-center, Dose Optimization and Dose Expansion Study to Assess the Safety and Efficacy of DFV890 in Adult Patients With Myeloid Diseases

Quick Facts

Study Start:2023-05-08
Study Completion:2027-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05552469

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 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
  2. 2. 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.
  3. 3. changes for dose expansion (applicable as of amendment 3):
  4. 1. 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.
  5. 2. LR CMML patients with symptomatic cytopenias and/or constitutional symptoms refractory, intolerant or unsuitable for standard first-line therapy.
  6. 3. 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.
  1. 1. Prior therapy for MDS administered for \>4 months (ESA and luspatercept administered for ≤4 months will be allowed if washout period followed)
  2. 2. Concurrent malignancy requiring active systemic therapy
  3. 3. Prior or concurrent cytotoxic chemotherapy for MDS at any time

Contacts and Locations

Study Locations (Sites)

Stanford Cancer Center
Stanford, California, 94305
United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Emory University School of Medicine-Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Northwestern University
Chicago, Illinois, 60611
United States
Sidney Kimmel CCC At JH
Baltimore, Maryland, 21231
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Weill Cornell Medicine NY-Presb
New York, New York, 10021
United States
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10065
United States
Vanderbilt University Medical Ctr
Nashville, Tennessee, 37232
United States
Univ of TX MD Anderson Cancer Cntr
Houston, Texas, 77030
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-08
Study Completion Date2027-02-01

Study Record Updates

Study Start Date2023-05-08
Study Completion Date2027-02-01

Terms related to this study

Keywords Provided by Researchers

  • MDS
  • CMML
  • CCUS
  • CHRS
  • NLRP3
  • Myelodysplastic Syndromes
  • Chronic Myelomonocytic Leukemia
  • inflammasome
  • CYP2C9

Additional Relevant MeSH Terms

  • Myeloid Diseases