A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

Running, not enrolling · Phase 1

Conditions studied: Myelodysplastic Syndromes (MDS)

In brief

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.

Key facts

Study ID

NCT02942290

Run by

AbbVie

People needed

129

Starts

2017-01-12

Expected to finish

2027-01-01

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.