St Louis, MONCT06240754Now EnrollingIRB Ready

Clonal Cytopenia of Undetermined Significance Clinical Trial in St Louis, MO

Access cutting-edge clonal cytopenia of undetermined significance treatment through this clinical trial at a research site in St Louis. Study-provided care at no cost to qualified participants.

Sponsored by Washington University School of Medicine

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Expert Care in St Louis

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related clonal cytopenia of undetermined significance treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to St Louis

    Convenient for MO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit St Louis site if eligible
  4. 4Begin participation

About This Clonal Cytopenia of Undetermined Significance Study in St Louis

Study researchers think that a drug called enasidenib may help people with clonal cytopenia of undetermined significance (CCUS) because the drug blocks the mutated IDH2 protein, which may improve blood cell counts. The purpose of this study is to find out whether enasidenib is a safe and effective treatment for CCUS.

Sponsor: Washington University School of Medicine

Who Can Participate

Inclusion Criteria

Unexplained cytopenia for at least 6 months. Cytopenia is defined as the presence of ≥1 blood count indexes below the following thresholds:
Hgb \<10 g/dL
ANC \<1.8 × 109/L
Platelets \<100 × 109/L
IDH2 gene mutation (R140 or R172), performed locally, at a frequency ≥ 2%.
At least 18 years of age.
ECOG performance status 0-2
Adequate organ function as defined below:
AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
Serum total bilirubin \< 1.5 x IULN (un upper limit of bilirubin 5 mg/dL is acceptable if it can be attributed to Gilbert's syndrome or erythropoiesis)
Creatinine clearance \> 50 mL/min by Cockcroft-Gault glomerular filtration rate estimation or serum creatinine ≤ 2 x IULN
The effects of enasidenib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 24 months after the last dose of enasidenib. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and for 4 months after the last dose of enasidenib.
Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion Criteria

Indication of hematologic disease by bone marrow biopsy within 6 months of study entry.
Evidence of disease progression from time of bone marrow biopsy to enrollment based on investigator review of symptoms and complete blood counts
Active malignancy (defined as \> 1 cm disease on most recent CT scan in the past 6 months).
Currently receiving therapy for solid tumor malignancy or received within the last 6 months.
Currently receiving any other investigational agents.
Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to enasidenib or other agents used in the study.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 72 hours of study entry.
Positive direct Coombs test.

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 St Louis?

Yes, this clinical trial (NCT06240754) has an active research site in St Louis, MO 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 St Louis, MO

If you're searching for clonal cytopenia of undetermined significance treatment options in St Louis, MO, this clinical trial (NCT06240754) 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 St Louis 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.

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