A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
NCT ID: NCT02942290
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1
129 participants
INTERVENTIONAL
2017-01-12
2027-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Participants With Relapsed/Refractory Myelodysplastic Syndromes (MDS)
NCT02966782
Clinical Study of Venetoclax Combined With Azacytiside in the Treatment of Myelodysplastic/Myeloproliferative Neoplasms in Adults
NCT05282719
A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)
NCT05829226
Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm
NCT05600894
Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS
NCT05342584
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Venetoclax + Azacitidine
Azacitidine
Powder for injection; taken subcutaneously (SC) or intravenous (IV); Administered on Days 1-7 of 28 days cycle or Days 1-5 of Week 1 \& Days 1-2 of Week 2 of 28 day cycle.
Venetoclax
Oral; Tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Azacitidine
Powder for injection; taken subcutaneously (SC) or intravenous (IV); Administered on Days 1-7 of 28 days cycle or Days 1-5 of Week 1 \& Days 1-2 of Week 2 of 28 day cycle.
Venetoclax
Oral; Tablet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Duplicate_University of Arizona Cancer Center - North Campus /ID# 154155
Tucson, Arizona, United States
The University of Chicago Medical Center /ID# 153673
Chicago, Illinois, United States
University of Maryland, Baltimore /ID# 153669
Baltimore, Maryland, United States
Tufts Medical Center /ID# 153672
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 152735
Boston, Massachusetts, United States
Washington University-School of Medicine /ID# 153671
St Louis, Missouri, United States
Columbia University Medical Center /ID# 153661
New York, New York, United States
Weill Cornell Medical College /ID# 155524
New York, New York, United States
Oregon Medical Research Center /ID# 152734
Portland, Oregon, United States
University of Pittsburgh MC /ID# 153662
Pittsburgh, Pennsylvania, United States
Tennessee Oncology-Nashville Centennial /ID# 222769
Nashville, Tennessee, United States
Vanderbilt University Medical Center /ID# 152738
Nashville, Tennessee, United States
UT MD Anderson Cancer Center /ID# 153809
Houston, Texas, United States
Concord Repatriation General Hospital /ID# 154958
Concord, New South Wales, Australia
Duplicate_St. Vincent's Hospital, Darlinghurst /ID# 222846
Darlinghurst, New South Wales, Australia
St George Hospital /ID# 154954
Kogarah, New South Wales, Australia
Liverpool Hospital /ID# 222410
Liverpool, New South Wales, Australia
Calvary Mater Newcastle /ID# 154957
Waratah, New South Wales, Australia
Duplicate_Princess Alexandra Hospital /ID# 154990
Woolloongabba, Queensland, Australia
Austin Health /ID# 154955
Heidelberg, Victoria, Australia
The Alfred Hospital /ID# 154956
Melbourne, Victoria, Australia
Fiona Stanley Hospital /ID# 222847
Murdoch, Western Australia, Australia
Juravinski Cancer Centre /ID# 152947
Hamilton, Ontario, Canada
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 153828
Nantes, Pays de la Loire Region, France
Hôpital Saint-Louis /ID# 153827
Paris, , France
Universitatsklinikum Mannheim /ID# 153140
Mannheim, Baden-Wurttemberg, Germany
Klinikum rechts der Isar /ID# 153139
Munich, Bavaria, Germany
Universitaetsklinikum Koeln /ID# 153141
Cologne, North Rhine-Westphalia, Germany
Duplicate_Universitaetsklinikum Carl Gus /ID# 153958
Dresden, Saxony, Germany
Universitaetsklinikum Leipzig /ID# 153142
Leipzig, Saxony, Germany
Universitaetsklinikum Halle (Saale) /ID# 153760
Halle, , Germany
Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 153763
Bologna, Emilia-Romagna, Italy
Duplicate_Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 153764
Rome, Roma, Italy
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 156492
Norwich, Norfolk, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 222567
Oxford, Oxfordshire, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 158810
Birmingham, , United Kingdom
King's College Hospital NHS Foundation Trust /ID# 156489
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Garcia JS, Platzbecker U, Odenike O, Fleming S, Fong CY, Borate U, Jacoby MA, Nowak D, Baer MR, Peterlin P, Chyla B, Wang H, Ku G, Hoffman D, Potluri J, Garcia-Manero G. Efficacy and safety of venetoclax plus azacitidine for patients with treatment-naive high-risk myelodysplastic syndromes. Blood. 2025 Mar 13;145(11):1126-1135. doi: 10.1182/blood.2024025464.
Related Links
Access external resources that provide additional context or updates about the study.
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-001657-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-507154-32-00
Identifier Type: OTHER
Identifier Source: secondary_id
M15-531
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.