Early Intervention in High Risk CCUS
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLachelle D. Weeks, MD, PhD
About this trial
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).
Eligibility criteria
Qualifiers
Age ≥18 years.
Hemoglobin (Hgb) <12 g/dL for women and <13g/dL for men
Absolute neutrophil count (ANC) < 1.8 × 109/L*
Platelet count (Plt) <150 × 109/L *Patients known to have a Duffy-null genotype must have anemia (Hgb < 12g/dL for women, Hgb <13g/dL for men) and/or thrombocytopenia (Plt < 150 × 109/L) to be eligible for this study.
Disqualifiers
Concurrent primary malignancy requiring active cytotoxic chemotherapy and/or ionizing radiation therapy.
Known inherited bone marrow failure disorder and/or germline predisposition to hematologic malignancy.
Receipt of anti-cancer therapy including any cytotoxic chemotherapy, ionizing radiation therapy, immunomodulatory agents such as lenalidomide, and targeted anti-cancer therapies including PARP inhibitors within the last 6 months. Patients with complete surgical resection of a tumor are not excluded from this study.
Anti-cancer therapy, including any cytotoxic chemotherapy, ionizing radiation therapy, immunomodulatory agents such as lenalidomide and targeted agents such as PARP inhibitors, planned in the next 6 months. Patients on hormonal adjuvant therapy for nonmetastatic breast and prostate cancer or other minimally-myelosuppressive maintenance therapies for non-metastatic cancer may be eligible at the discretion of the study PI.
Trial design
Treatments tested in this trial
- Inqovi
Treatment groups
108 Participants
are divided into 2 treatment groupsSponsors and collaborators
Lachelle D. Weeks, MD, PhD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Astex Pharmaceuticals, Inc.
Collaborator
Break Through Cancer
Collaborator
Source ClinicalTrials.gov