NCT02942290
Brief summary
This is a Phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating an active drug in combination with azacitidine in subjects with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
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.
