Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 12:58 AM
NCT ID:
NCT03047993
Eligibility Criteria:
Inclusion Criteria:
* Signed, informed consent must be obtained prior to any study specific procedures
* Subjects with a histologically confirmed diagnosis of MDS, including both MDS and refractory anemia with excess blasts (RAEB)-T (acute myeloid leukemia \[AML\] with 20-30% blasts and multilineage dysplasia by French-American-British \[FAB\] criteria) by World Health Organization (WHO) and chronic myelomonocytic leukemia (CMML) are eligible
* Subjects with high-risk MDS (i.e. International Prognostic Scoring System \[IPSS\] Intermediate-2 or high-risk; or R-IPSS high or very-high risk). Patients with Intermediate-1 risk by IPSS or Intermediate risk by R-IPSS and with IDH1 or IDH2, or high-risk molecular features including TP53, ASXL1, EZH2, and/or RUNX1 mutations are also eligible
* Subjects with prior hypomethylating agent therapy exposure may be eligible based on discussion with the principal investigator (PI)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Serum bilirubin =\< 2 x the upper limit of normal (ULN) (except for patients with Gilbert's disease)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =\< 3 x the laboratory ULN
* Creatinine clearance \> 30 mL/min based on the Cockcroft-Gault equation
* Able to understand and voluntarily sign a written informed consent, and willing and able to comply with protocol requirements
* Resolution of all treatment-related, non-hematological toxicities, except alopecia, from any previous cancer therapy to \< grade 1 prior to the first dose of study treatment
* Female patients of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for a minimum of 3 months following the last dose of study drug. Post-menopausal females (\>= 45 years old and without menses for \>= 1 year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception during the study and for a minimum of 3 months following the last dose of study drug if sexually active with a female of childbearing potential
Exclusion Criteria:
* Any prior or coexisting medical condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study
* Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures
* Active uncontrolled infection at study enrollment including known diagnosis of human immunodeficiency virus or chronic active hepatitis B or C infection
* Clinically significant gastrointestinal conditions or disorders that may interfere with study drug absorption, including prior gastrectomy
* Patients with known active central nervous system (CNS) disease, including leptomeningeal involvement
* Impaired cardiac function, uncontrolled cardiac arrhythmia, or clinically significant cardiac disease including the following: a) New York Heart Association grade III or IV congestive heart failure, b) myocardial infarction within the last 6 months
* Subjects with a corrected QT (QTc) \> 480 ms (QTc \> 510 msec for subjects with a bundle branch block at baseline)
* Nursing or pregnant women
* Subjects with known hypersensitivity to study drugs or their excipients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03047993
Study Brief:
Protocol Section:
NCT03047993