A Study Evaluating Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
Trial Status: Closed to Accrual
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.
- 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
- - 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.
Banner University Medical Center - Tucson
Contact: Brittney Fishback
University of Chicago Comprehensive Cancer Center
University of Maryland / Greenebaum Cancer Center
Contact: Emade Ebah
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Siteman Cancer Center at Washington University
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
OHSU Knight Cancer Institute
Vanderbilt University / Ingram Cancer Center
M D Anderson Cancer Center
Trial Phase Phase I
Trial Type Treatment
- Primary ID M15-531
- Secondary IDs NCI-2016-01891, 2016-001657-41
- Clinicaltrials.gov ID NCT02942290