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

  • STATUS
    Recruiting
  • End date
    Oct 6, 2023
  • participants needed
    15
  • sponsor
    Memorial Sloan Kettering Cancer Center
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Updated on 6 May 2022
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Summary

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.

Details
Condition Clonal Cytopenia of Undetermined Significance, CCUS Clonal Cytopenia of Undetermined Significance
Treatment Enasidenib
Clinical Study IdentifierNCT05102370
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on6 May 2022

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), performed locally, 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
Patients being enrolled on study on the basis of anemia, will only be eligible if
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
folate, B12, serum iron, serum ferritin, total iron binding capacity
haptoglobin and peripheral smear within normal limits
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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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