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New treatment option for Clonal Cytopenia of Undetermined Significance
Official title Early Intervention in High Risk CCUS
ClinicalTrials.gov ID: NCT06802146
What this study is testing
What is Inqovi?
Inqovi is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for clonal cytopenia of undetermined significance.
Also referred to as Decitabine and Cedazuridine, ASTX727.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years.
- Unexplained cytopenia(s) for at least 4 months (at least two separate labs within 4 months including at time of screening must meet this criteria)...
- 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)...
You likely can't join if
- 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...
- Anti-cancer therapy, including any cytotoxic chemotherapy, ionizing radiation therapy, immunomodulatory agents such as lenalidomide and targeted...
- Diagnosis of MDS, MPN, CMML, AML or any other hematolymphoid malignancy in the patient's lifetime. This includes individuals with MDS-defining...
- Presence of a concurrent hematologic malignancy precursor state, such as smoldering multiple myeloma (SMM), and smoldering Waldenstrom's...
See the full eligibility criteria
- Age ≥18 years.
- Unexplained cytopenia(s) for at least 4 months (at least two separate labs within 4 months including at time of screening must meet this criteria). Cytopenia(s) defined as the presence of ≥ 1 of the following:
- 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...
- 1 pathogenic variant detected in any myeloid driver gene with a VAF of at least 0.02 (2%) identified by local next generation sequencing (NGS) of peripheral blood or bone marrow sample within 3 months from screening...
- Participants must have a high risk score per the Clonal Hematopoiesis Risk Calculator (CHRS). See APPENDIX C for calculation.
- Screening bone marrow biopsy must not be diagnostic of any overt hematologic malignancy by morphologic assessment and must be consistent with a diagnosis of clonal cytopenia of unknown significance (CCUS) as determined...
- ECOG performance status 0-2 (see Appendix A).
- Participants must meet the following organ function as defined below:
- Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤3x upper limit of normal (ULN).
- Serum total bilirubin \<1.5x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis or Gilbert's syndrome. In these cases, approval from the study Sponsor-Investigator is required.
- Creatinine clearance greater than 40 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation.
- Ability to understand and the willingness to sign a written informed consent document.
- For participants of the early pharmacologic intervention cohort: women of childbearing potential must use highly effective contraception during treatment for at least 6 months after the last dose and males with female...
- 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...
- 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...
- Diagnosis of MDS, MPN, CMML, AML or any other hematolymphoid malignancy in the patient's lifetime. This includes individuals with MDS-defining chromosomal abnormalities identified via conventional karyotype or FISH.
- Presence of a concurrent hematologic malignancy precursor state, such as smoldering multiple myeloma (SMM), and smoldering Waldenstrom's macroglobulinemia.
- Presence of an early-stage hematologic precursor state-such as monoclonal gammopathy of undetermined significance (MGUS) and monoclonal B cell lymphocytosis (MBL).
- Active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other...
- Recent (within 3 months) vaccination with any live attenuated vaccine or vaccination with live attenuated vaccine planned during the next 15 months. \ Live attenuated vaccines include measles, mumps, rubella (MMR...
- Laboratory evidence indicative of clinically significant red cell hemolysis.
- Hypersplenism and/or evidence of portal hypertension on physical exam or imaging.
- Pregnant or lactating.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.