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

NCT02942290

CompletedPhase 1

Sponsor: AbbVie

Conditions: Myelodysplastic Syndromes (MDS)

Interventions: Azacitidine, Venetoclax

Countries: United States, Australia, Canada, France, Germany, Italy, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
Locations (37)
  • Tucson, Arizona, United States
  • Chicago, Illinois, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • New York, New York, United States
  • Portland, Oregon, United States
  • Pittsburgh, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Concord, New South Wales, Australia
  • Darlinghurst, New South Wales, Australia
  • Kogarah, New South Wales, Australia
  • Liverpool, New South Wales, Australia
  • Waratah, New South Wales, Australia
  • Woolloongabba, Queensland, Australia
  • Heidelberg, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Murdoch, Western Australia, Australia
  • Hamilton, Ontario, Canada
  • Nantes, Pays de la Loire Region, France
  • Paris, France
  • Mannheim, Baden-Wurttemberg, Germany
  • Munich, Bavaria, Germany
  • Cologne, North Rhine-Westphalia, Germany
  • Dresden, Saxony, Germany
  • Leipzig, Saxony, Germany
  • + 7 more on CT.gov