Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
With
Celgene; Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
