Early Intervention in High Risk CCUS

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Lachelle D. Weeks, MD, PhD
Study ID
NCT06802146
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Clonal Cytopenia of Undetermined Significance
  • Cytopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inqovi — DRUG
    Combination of a nucleoside metabolic inhibitor and cytidine deaminase inhibitor, 10mg DEC / 100mg CED tablet, taken orally per protocol.

Study Details

This research is being done to find out more about the potential risks and benefits of early treatment in participants with high risk Clonal Cytopenia of Unknown Significance (CCUS). This study will give eligible CCUS participants the option of either being observed or taking an oral drug as treatment. The names of the study drug involved in this study is: -Decitabine/cedazuridine (DEC/CED) (a nucleoside metabolic inhibitor and cytidine deaminase inhibitor).

Key Dates

Start date
Feb 7, 2025
Status verified
Apr 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2028

Study Design

Enrollment
108 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Inqovi Cohort
    Participants will be enrolled and will complete: * Baseline visit. * In-clinic visits with assessments: Cycle 1 days 8, 15, and 22. * In-clinic visits with assessments and bone marrow biopsies: Cycles 2 - 12 Day 1. * Cycle 1 - 12: • Days 1 - 5 of 28 day cycle: Predetermined dose of Inqovi 1x daily. * End of Treatment visit, Cycle 13 Day 1, with assessments and bone marrow biopsy. * Follow up in-clinic visits with assessments: Cycle 19 Day 21, Cycle 25 Day 1, Cycle 31 Day 1, and Cycle 36 Day 28. Bone marrow biopsy at Cycle 25 Day 1. * End of Study visit, Cycle 36 Day 28, with assessments and bone marrow biopsy.
  • No Intervention: Observational Cohort
    Participants will complete: * Baseline visit. * In-clinic visits with assessments: Cycle 7 Day 1, Cycle 13 Day, Cycle 19 Day, Cycle 25 Day 1, and Cycle 31 Day 1. * Bone marrow biopsies every 12 months at Cycle 13 Day 1 and Cycle 25 Day. * End of study visit, Cycle 36 Day 28, with assessments and bone marrow biopsy.

Primary Outcome Measure

Feasibility Failure Rate (FFR) [ Time Frame: Treatment duration up to 12 cycles (28 days per cycle). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Lachelle Weeks, MD
[email protected]
617-632-3779
Lachelle Weeks, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MA

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