Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    15
  • sponsor
    Washington University School of Medicine
Updated on 21 April 2022

Summary

This is an open-label, multicenter study exploring the efficacy of ivosidenib in patients with clonal cytopenia of undetermined significance (CCUS) with mutations in IDH1. The purpose is to establish proof of principle that ivosidenib is well-tolerated and potentially efficacious in improving blood count abnormalities in these patients.

Details
Condition Clonal Cytopenia of Undetermined Significance
Treatment Ivosidenib
Clinical Study IdentifierNCT05030441
SponsorWashington University School of Medicine
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

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 × 10^9/L
Platelets <100 × 10^9/L
IDH1 gene mutation (R132) confirmed by droplet digital PCR (ddPCR) testing, at a
frequency > 2%. This will be performed locally and confirmed at Washington
University
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 (an upper limit of bilirubin 5mg/dL is acceptable if it can be attributed to Gilbert's syndrome or erythropoiesis)
Serum creatinine < 2 x IULN or creatinine clearance > 50 mL/min by Cockcroft-Gault glomerular filtration rate estimation
The effects of ivosidenib on the developing human fetus are unknown. For this reason
women of childbearing potential and men must agree to use adequate
contraception (defined in Section 5.5) prior to study entry, for the duration
of study participation, and for 90 days after the last dose of ivosidenib
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 90 days after the
last dose of ivosidenib
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)

Exclusion Criteria

Indication of hematologic disease by bone marrow biopsy within 1 month of study entry
Active malignancy (defined as > 1 cm disease on most recent CT scan in the past 6 months)
Currently receiving therapy for solid tumor malignancy
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 ivosidenib 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
Heartrate corrected QT interval (QTc) > 450 msec or with other factors that increase the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalemia, family history of long QT interval syndrome)
Known medical history of progressive multifocal leukoencephalopathy (PML)
Currently taking medications known to be CYP3A4 strong inducers and sensitive substrates
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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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