A Phase 1b Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
This is a Phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating venetoclax in combination with azacitidine in subjects with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.
18 Years and up
Accepting Healthy Volunteers?
- Participant must have documented diagnosis of de novo MDS with:
- International Prognostic Scoring System (IPSS) risk categories Int-2 or High (minimum IPSS overall score of 1.5) and
- Presence of less than 20% bone marrow blasts per bone marrow
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
- Participant is not a candidate to undergo intensive chemotherapy or allogeneic hematopoietic stem cell transplantation (HSCT).
- Participant has received prior therapy for MDS. (Prior supportive care in form of transfusions or growth factors, etc., is not considered prior therapy.)
- Participant has received prior therapy with a BH3 mimetic.
- Participant has a diagnosis other than previously untreated de novo MDS with IPSS risk categories Int-2 or High, including:
- MDS with IPSS risk categories Low or Int-1 (overall IPSS score < 1.5)
- Therapy-related MDS (t-MDS)
- MDS evolving from a pre-existing myeloproliferative neoplasm (MPN)
- MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN
- Participant has received allogeneic HSCT or solid organ transplantation.
- Participant has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug.