Last updated on June 2019

A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Subjects With Relapsed/Refractory Myelodysplastic Syndromes (MDS)


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Preleukemia | MYELODYSPLASTIC SYNDROME
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 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:
    1. 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
    2. 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.

Exclusion Criteria:

  • 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.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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