Myelodysplastic Syndrome Clinical Trial
A Study Evaluating Venetoclax in Combination With Azacitidine in Participants 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 participants with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.
Participant must have documented diagnosis of untreated de novo MDS with:
International Prognostic Scoring System (IPSS) risk categories Int-2 or High (minimum IPSS overall score of 1.5) OR Revised IPSS (IPSS-R) categories intermediate, high or very high (score of > 3) and
Presence of less than 20% bone marrow blasts per bone marrow biopsy/aspirate.
Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
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 BCL-2 Homology 3 (BH3) mimetic.
Participant has a diagnosis other than previously untreated de novo MDS (as defined in the protocol) 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 Hematopoietic Stem Cell Transplantation (HSCT) or solid organ transplantation.
Participant has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug.
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There are 37 Locations for this study
Tucson Arizona, 85719, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02215, United States
Saint Louis Missouri, 63110, United States
New York New York, 10032, United States
New York New York, 10065, United States
Portland Oregon, 97239, United States
Pittsburgh Pennsylvania, 15260, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Concord New South Wales, 2139, Australia
Darlinghurst New South Wales, 2010, Australia
Kogarah New South Wales, 2217, Australia
Liverpool New South Wales, 2170, Australia
Waratah New South Wales, 2298, Australia
Woolloongabba Queensland, 4102, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3004, Australia
Murdoch Western Australia, 6150, Australia
Hamilton Ontario, L8V 1, Canada
Nantes Pays-de-la-Loire, 44000, France
Paris , 75010, France
Mannheim Baden-Wuerttemberg, 68167, Germany
Köln Nordrhein-Westfalen, 50937, Germany
Dresden Sachsen, 01307, Germany
Leipzig Sachsen, 04103, Germany
Halle (Saale) , 06120, Germany
Munich , 81675, Germany
Rome Lazio, 00161, Italy
Bologna , 40138, Italy
Norwich Norfolk, NR4 7, United Kingdom
Oxford Oxfordshire, OX3 9, United Kingdom
Birmingham , B15 2, United Kingdom
London , SE5 9, United Kingdom
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