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New treatment option for Clonal Cytopenia of Undetermined Significance
Official title Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial
ClinicalTrials.gov ID: NCT06240754
What this study is testing
What is Enasidenib?
Enasidenib is an investigational medicine, being studied as a potential treatment for clonal cytopenia of undetermined significance.
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
- 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.
- Phase 2: a mid-size study of how well it works
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
- 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%.
You likely can't join if
- 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...
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, 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 St Louis, Missouri, 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.