Myelodysplastic Syndrome Clinical Trial
A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Participants With Relapsed/Refractory Myelodysplastic Syndromes (MDS)
This is a Phase 1b, open-label, multicenter study designed to evaluate the safety and pharmacokinetics of venetoclax as a single-agent and in combination with azacitidine in participants with relapsed/refractory Myelodysplastic Syndromes (MDS).
Subjects who have relapsed or refractory MDS.
Subject enrolled in venetoclax monotherapy must have documented failure of prior therapy with a hypomethylating agent (HMA). HMA-failure is defined as:
Relapse after initial complete or partial response or hematological improvement after at least 4 cycles of azacitidine or at least 4 cycles of decitabine within the last 5 years, OR
Failure to achieve complete or partial response or hematological improvement after at least 4 cycles of azacitidine or at least 4 cycles of decitabine within the last 5 years
Subjects must have presence of < 20% bone marrow blasts per bone marrow biopsy/aspirate at screening.
Subject is not a candidate to undergo allogenic hematopoietic stem cell transplantation (HSCT).
Subject must have an Eastern Cooperative Oncology Group (ECOG) performance score of ≤2.
Subject must have adequate hematologic, renal, and hepatic function.
Subject has received prior therapy with a BH3 mimetic.
Subject has MDS evolving from a pre-existing myeloproliferative neoplasm (MPN).
Subject has MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
Subject has received allogeneic HSCT or solid organ transplantation.
Subject has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug.
Subject is pregnant or breastfeeding.
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There are 23 Locations for this study
Tucson Arizona, 85719, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06510, United States
Chicago Illinois, 60637, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Worcester Massachusetts, 01655, United States
New York New York, 10032, United States
Portland Oregon, 97239, United States
Houston Texas, 77030, United States
Kogarah New South Wales, 2217, Australia
Liverpool New South Wales, 2170, Australia
Fitzroy Melbourne Victoria, 3065, Australia
Parkville Victoria, 3050, Australia
Perth Western Australia, 6000, Australia
Mannheim Baden-Wuerttemberg, 68167, Germany
Duesseldorf Nordrhein-Westfalen, 40479, Germany
Düsseldorf Nordrhein-Westfalen, 40225, Germany
Köln Nordrhein-Westfalen, 50937, Germany
Leipzig Sachsen, 04103, Germany
Dresden , 01307, Germany
Halle (Saale) , 06120, Germany
Munich , 81675, Germany
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