Instructions
If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.
- Adult male or female, at least 18 years old
- Diagnosis of MDS according to the 2016 WHO classification with presence of <20% bone marrow blasts per bone marrow biopsy/aspirate at screening
- Patients must have adequate liver functions as demonstrated by clinical laboratory assessments
- No prior therapy for MDS with any hypomethylating agent, chemotherapy, or allogeneic stem cell transplantation
- Overall Revised International Prognostic Scoring System (IPSS-R) score >3 (intermediate, high, or very high)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Hematopoietic Stem Cell Transplant (HSCT) eligible with no pre-arranged HSCT at the time of Study Day 1, or HSCT ineligible without a plan for HSCT at the time of Study Day 1
- Therapy-related MDS (tMDS)
- MDS evolving from a pre-existing myeloproliferative neoplasm (MPN)
- MDS/MPN including chronic myelomonocytic leukemia (CMML, atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML), and unclassified MDS/MPNHistory of any active malignancy within the past 2 years prior to screening, with the exception of:
- Adequately treated carcinoma in situ of the uterine cervix;
- Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin;
- Asymptomatic prostate cancer without known metastatic disease, and with no requirement for therapy
- Conditions that could interfere with drug absorption
- Prior treatment with lenalidomide, anti-thymocyte globulin (ATG), and cyclosporin, as these are considered disease-modifying agents
- Prior therapy with a BH3 mimetic
- Females who are pregnant, breastfeeding, or considering becoming pregnant during the study
- Patients who have tested positive for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV)