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.
Status:
Recruiting
Associated Drug(s):
Phase:
Phase 3
Gender:
Female
Male
Age Group:
18 years and older
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)