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

Status: Active

Description

This is a Phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating venetoclax in combination with azacitidine in subjects with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.

Eligibility Criteria

Inclusion Criteria

  • Participant must have documented diagnosis of de novo MDS with:
  • International Prognostic Scoring System (IPSS) risk categories Int-2 or High (IPSS overall score ≥ 1.5) and
  • Presence of less than 20% bone marrow blasts per bone marrow
  • Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to
  • - Participant is not a candidate to undergo intensive chemotherapy or allogeneic hematopoietic stem cell transplantation (HSCT).

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 BH3 mimetic.
  • Participant has a diagnosis other than previously untreated de novo MDS with IPSS risk categories Int-2 or High, 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 HSCT or solid organ transplantation.
  • Participant has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug.

Locations & Contacts

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Emade Ebah
Phone: 410-328-6881
Email: emade.ebah@umm.edu

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Abbvie

Trial IDs

Primary ID M15-531
Secondary IDs NCI-2016-01891, 2016-001657-41
Clinicaltrials.gov ID NCT02942290