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:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-24 @ 12:04 PM
NCT ID:
NCT02308761
Eligibility Criteria:
Inclusion Criteria:
* RR-AML
* Relapsed/refractory MDS
* Participants with a history of allogeneic stem cell transplant are eligible for study participation provided the following eligibility criteria are met:
1. Transplant was more than (\>) 100 days prior to study enrollment
2. Participant has not taken immunosuppressive medications for at least 2 weeks
3. No signs or symptoms of graft versus host disease other than Grade 1 skin involvement
4. No active infection
* Eastern Cooperative Oncology Group Performance Status score equal to or less than (\<=) 2
* Life expectancy of at least 2 months
* Disease-free of active second/secondary or prior malignancies for equal to or more than (\>=) 1 year with the exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast
* Adequate hematological, renal, hepatic and coagulation laboratory test results
* Women of childbearing potential and men must agree to use adequate contraception from 28 days prior to the first dose of the study drug, during the entire Treatment Period, and for at least 28 days after the last dose of the study drug
Exclusion Criteria:
* New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia
* Have Fridericia-corrected QT interval \> 470 milliseconds (msec) (female) or \> 450 msec (male), or history of congenital long QT syndrome
* Uncontrolled bacterial, viral, or fungal infections
* Known clinically important respiratory impairment
* Positive for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C antibodies
* History of major organ transplant
* Symptomatic central nervous system disease, malignancy, or metastasis
* Pregnant or nursing
* Concomitant chemotherapy, radiation therapy, immunotherapy, biologic therapy, or hormonal therapy
* Treatment with surgery or chemotherapy within 21 days prior to study entry
* Prior treatment with small molecule bromodomain and extra terminal family inhibitor
* Radiation for symptomatic lesions within 14 days of study enrollment
* Active substance abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02308761
Study Brief:
Protocol Section:
NCT02308761