Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06802146

Early Intervention in High Risk CCUS

Led by Lachelle D. Weeks, MD, PhD · Updated on 2026-04-23

108

Participants Needed

1

Research Sites

199 weeks

Total Duration

On this page

Sponsors

L

Lachelle D. Weeks, MD, PhD

Lead Sponsor

A

Astex Pharmaceuticals, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Early Intervention in High Risk CCUS

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6518 years.
  • Unexplained low blood counts for at least 4 months confirmed by at least two lab tests.
  • Low hemoglobin (less than 12 g/dL for women, less than 13 g/dL for men), or low neutrophil count (less than 1.8 x 10^9/L), or low platelet count (less than 150 x 10^9/L).
  • For patients with Duffy-null genotype, anemia or low platelets required.
  • Presence of at least one pathogenic variant in myeloid driver genes with variant allele frequency of at least 2% detected within 3 months before screening.
  • High risk score on the Clonal Hematopoiesis Risk Calculator.
  • Bone marrow biopsy showing clonal cytopenia of unknown significance without blood cancer.
  • ECOG performance status 0 to 2.
  • Adequate liver and kidney function as defined by laboratory tests.
  • Ability and willingness to provide informed consent.
  • Women of childbearing potential must use effective contraception during treatment and for 6 months after; males with female partners must use contraception during treatment and for 3 months after (for intervention group).
Not Eligible

You will not qualify if you...

  • Active primary cancer requiring chemotherapy or radiation.
  • Known inherited bone marrow failure or genetic risk for blood cancer.
  • Anti-cancer treatment within the last 6 months.
  • Planned anti-cancer treatment in the next 6 months, except certain hormonal or maintenance therapies at investigator discretion.
  • Any prior diagnosis of MDS, MPN, CMML, AML, or other blood cancers.
  • Presence of other blood cancer precursor states such as smoldering multiple myeloma or Waldenstrom's macroglobulinemia.
  • Early-stage blood conditions like MGUS or monoclonal B cell lymphocytosis.
  • Active uncontrolled infections.
  • Recent or planned live attenuated vaccinations within specified timeframes.
  • Evidence of significant red blood cell destruction.
  • Hypersplenism or portal hypertension.
  • Pregnant or lactating individuals.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

L

Lachelle Weeks, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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