Vanderbilt Clinical Trials

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

Purpose

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.

Condition

Myelodysplastic Syndromes (MDS)

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Venetoclax + Azacitidine		Drug: Azacitidine Powder for injection; taken subcutaneously (SC) or intravenous (IV); Administered on Days 1-7 of 28 days cycle or Days 1-5 of Week 1 & Days 1-2 of Week 2 of 28 day cycle. Drug: Venetoclax Oral; Tablet Other names: ABT-199 GDC-0199 VENCLEXTA

More Details

Status: Active, not recruiting
Sponsor: AbbVie

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.