ACTIVE_NOT_RECRUITING

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

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Conditions

Clonal Cytopenia of Undetermined Significance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. The study will also be offered in a decentralized, remote structure to patients.

Official Title

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

Quick Facts

Study Start:2022-04-01
Study Completion:2030-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05030441

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Unexplained cytopenia for at least 6 months. Cytopenia is defined as the presence of ≥1 blood count indexes below the following thresholds:
  2. * Hgb \<10 g/dL
  3. * ANC \<1.8 × 10\^9/L
  4. * Platelets \<100 × 10\^9/L
  5. * 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.
  6. * At least 18 years of age.
  7. * ECOG performance status 0-2
  8. * Adequate organ function as defined below:
  9. * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  10. * 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)
  11. * Serum creatinine \< 2 x IULN or creatinine clearance \> 50 mL/min by Cockcroft-Gault glomerular filtration rate estimation
  12. * 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.
  13. * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
  1. * Indication of hematologic disease by bone marrow biopsy within 6 months of study entry.
  2. * Active malignancy (defined as \> 1 cm disease on most recent CT scan in the past 6 months).
  3. * Currently receiving therapy for solid tumor malignancy.
  4. * Currently receiving any other investigational agents.
  5. * Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
  6. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ivosidenib or other agents used in the study.
  7. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  8. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 72 hours of study entry.
  9. * 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).
  10. * Known medical history of progressive multifocal leukoencephalopathy (PML).
  11. * Currently taking medications known to be CYP3A4 strong inducers and sensitive substrates.

Contacts and Locations

Principal Investigator

Kelly Bolton, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Cleveland Clinic - Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Kelly Bolton, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-01
Study Completion Date2030-01-31

Study Record Updates

Study Start Date2022-04-01
Study Completion Date2030-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Clonal Cytopenia of Undetermined Significance