Is NCT07579429 recruiting in Aurora, CO?

Yes, NCT07579429 is currently recruiting participants at its Aurora, CO location. This clonal cytopenia of undetermined significance clinical trial is actively enrolling qualified participants.

Is participation in this Aurora clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Clonal Cytopenia of Undetermined Significance Clinical Trial in Aurora, CO

Q: How do I join the clonal cytopenia of undetermined significance clinical trial in Aurora?

To join this clinical trial in Aurora, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Clonal Cytopenia of Undetermined Significance Study in Aurora

This is an open-label, phase 2 study for lower risk MDS and high risk CCUS patients who are transfusion independent. There will be two cohorts enrolled at the same time to measure the effect of nicotinamide riboside and pterostilbene at different doses. The primary goals of the study are: * to assess if study drug improves cytopenias in patients * to determine safety of the study drug in patients

Sponsor: University of Colorado, Denver

Who Can Participate

Inclusion Criteria

Subject must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any research directed procedures.

Stated willingness to comply with all study procedures and be available for the duration of the study.

Be a male or female aged ≥ 18 years of age.

For persons of reproductive potential, use of highly effective method(s) of contraception.

Subject must have confirmation of high risk CCUS (defined by CHRS score) or the diagnosis of MDS in the lower risk category as defined by IPSS-M less than 0.

Patients must have ECOG of ≤ 2

Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.

Subject must have adequate liver function as demonstrated by:

aspartate aminotransferase (AST) ≤ 3.0 × ULN

alanine aminotransferase (ALT) ≤ 3.0 × ULN

Unless due to Gilbert's syndrome, patients must have a total bilirubin ≤ 3 × ULN.

Subject is informed that consumption of the following fruits is prohibited 3 days prior to the initiation of study treatment and throughout participation: grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit.

Exclusion Criteria

Subject is known to be positive for HIV with uncontrolled disease. HIV testing is not required.

Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load. Hepatitis B or C testing is not required and subjects with serologic evidence of prior vaccination to HBV may participate.

Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:

Significant active cardiac disease within the previous 6 months including: New York Heart Association heart failure \> class 2, unstable angina, or myocardial infarction.

Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.

Subject has a malabsorption syndrome or other condition that precludes enteral route of administration. This includes history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease (e.g. sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity.

Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal). Uncontrolled is defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment.

Subject has a history of other malignancies prior to study entry, with the exception of:

Adequately treated in situ carcinoma of the breast or cervix uteri

Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin

Prostate cancer not requiring therapy beyond hormonal therapy

Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent

Any subject who is transfusion dependent and a candidate for MDS therapy such as erythroid stimulating agents, thrombopoietin receptor agonists, Lusparercept, Imetelstat or hypomethylating agents.

Pregnant or breast-feeding females. A pregnancy test will be obtained at the time of screening if applicable.

Known or suspected hypersensitivity to nicotinamide riboside and pterostilbene.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Aurora?

Yes, this clinical trial (NCT07579429) has an active research site in Aurora, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Clonal Cytopenia of Undetermined Significance Treatment Options in Aurora, CO

If you're searching for clonal cytopenia of undetermined significance treatment options in Aurora, CO, this clinical trial (NCT07579429) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Aurora research site is actively enrolling participants for this clinical trial. You'll receive care from experienced clonal cytopenia of undetermined significance specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all clonal cytopenia of undetermined significance clinical trials near you to find additional studies recruiting in your area.

Clonal Cytopenia of Undetermined Significance Clinical Trial in Aurora, CO

Expert Care in Aurora

IRB Approved

No-Cost Care

Apply for This Aurora Location

Why Participate?

Simple Process