A Study of Enasidenib in People With Clonal Cytopenia of Undetermined Significance

Condition	Clonal Cytopenia of Undetermined Significance, CCUS Clonal Cytopenia of Undetermined Significance
Age	18years or above
Treatment	Enasidenib
Clinical Study Identifier	NCT05102370
Sponsor	Memorial Sloan Kettering Cancer Center
Last Modified on	2 December 2024

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Step 4 Get your study results

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age ≥18 years at the time of signing the informed consent form
	Willing and able to adhere to the study visit schedule and other protocol requirements
	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 × 10^9/L
	Platelets <100 × 10^9/L
	Results of bone marrow biopsy within 1 month of study entry (screening bone marrow biopsy) must not indicate hematologic disease
	IDH2 gene mutation (R140 or R172), confirmed by droplet digital PCR (ddPCR) testing, at a frequency >2%
	ECOG performance status of 0-2
	Adequate organ function, defined as
	Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤3x upper limit of normal (ULN), unless the subject has Gilbert's syndrome
	Serum total bilirubin <1.5x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis. In these cases, approval from the study Principal Investigator is required
	Creatinine clearance greater than 50 mL/min based on the Cockroft-Gault glomerular filtration rate estimation
	Folate, B12, serum iron, serum ferritin, total iron binding capacity, haptoglobin and
	peripheral smear within normal limits
	Women of childbearing potential may participate provided they have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test within 72 h of starting treatment
	Women of childbearing potential (WOCBP) and males with partners who are WOCBP must agree to abstain from sexual intercourse or to use 1 highly effective form of contraception during the study and for at least 4 months following the last dose of enasidenib. Males with partners who are WOCBP must agree to use a barrier method
Exclusion Criteria
	Active malignancy defined as >1-cm disease on most recent CT scan in the past 6 months or recent history of cancer (i.e. within the past 5 years) with >50% chance of cancer recurrence in the next 5 years
	Current or prior history of hematologic malignancy
	Therapy (including maintenance therapy) for solid-tumor malignancy within the last 6 months
	Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally
	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 treatment)
	Positive direct Coombs test
	Evidence of hypersplenism on physical exam
	Pregnant or lactating (women)

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A Study of Enasidenib in People With Clonal Cytopenia of Undetermined Significance

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