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

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 cohort.

Study Start Date

March, 13 2017

Estimated Completion Date

December 2020

Interventions

  • Drug: Azacitidine
  • Drug: Venetoclax

Study ID

AbbVie -- M15-531

Status

Recruiting

Trial ID

NCT02942290

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

56

Sponsor

AbbVie

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 greater than or equal to 5% and less than 20% bone marrow blasts per bone marrow
  • Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
  • 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.

Gender

All

Ages

18 Years to 99 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (55)

Study Location Distance Name Phone Email
Dana Farber Cancer Institute ID 164585 - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute ID 164585 - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute ID 164585 - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute ID 164585 - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute ID 164585 - Boston, Massachusetts 2.4 miles None None None
Tufts Medical Center ID 153672 - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center ID 153672 - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center ID 153672 - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center ID 153672 - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center ID 153672 - Boston, Massachusetts 3.2 miles None None None
Columbia University Medical Center ID 153661 - New York, New York 181.2 miles None None None
Columbia University Medical Center ID 153661 - New York, New York 181.2 miles None None None
Columbia University Medical Center ID 153661 - New York, New York 181.2 miles None None None
Columbia University Medical Center ID 153661 - New York, New York 181.2 miles None None None
Columbia University Medical Center ID 153661 - New York, New York 181.2 miles None None None
Weill Cornell Medical College of Cornell University ID 155524 - New York, New York 184.8 miles None None None
Weill Cornell Medical College of Cornell University ID 155524 - New York, New York 184.8 miles None None None
Weill Cornell Medical College of Cornell University ID 155524 - New York, New York 184.8 miles None None None
Weill Cornell Medical College of Cornell University ID 155524 - New York, New York 184.8 miles None None None
Weill Cornell Medical College of Cornell University ID 155524 - New York, New York 184.8 miles None None None
Univ of MD Baltimore ID 153669 - Baltimore, Maryland 358.9 miles None None None
Univ of MD Baltimore ID 153669 - Baltimore, Maryland 358.9 miles None None None
Univ of MD Baltimore ID 153669 - Baltimore, Maryland 358.9 miles None None None
Univ of MD Baltimore ID 153669 - Baltimore, Maryland 358.9 miles None None None
Univ of MD Baltimore ID 153669 - Baltimore, Maryland 358.9 miles None None None
UPMC Hillman Cancer Center ID 153662 - Pittsburgh, Pennsylvania 477.2 miles None None None
UPMC Hillman Cancer Center ID 153662 - Pittsburgh, Pennsylvania 477.2 miles None None None
UPMC Hillman Cancer Center ID 153662 - Pittsburgh, Pennsylvania 477.2 miles None None None
UPMC Hillman Cancer Center ID 153662 - Pittsburgh, Pennsylvania 477.2 miles None None None
UPMC Hillman Cancer Center ID 153662 - Pittsburgh, Pennsylvania 477.2 miles None None None
The University of Chicago Medical Center ID 153673 - Chicago, Illinois 848.0 miles None None None
The University of Chicago Medical Center ID 153673 - Chicago, Illinois 848.0 miles None None None
The University of Chicago Medical Center ID 153673 - Chicago, Illinois 848.0 miles None None None
The University of Chicago Medical Center ID 153673 - Chicago, Illinois 848.0 miles None None None
The University of Chicago Medical Center ID 153673 - Chicago, Illinois 848.0 miles None None None
Henry Joyce Cancer Clinic ID 152738 - Nashville, Tennessee 944.2 miles None None None
Henry Joyce Cancer Clinic ID 152738 - Nashville, Tennessee 944.2 miles None None None
Henry Joyce Cancer Clinic ID 152738 - Nashville, Tennessee 944.2 miles None None None
Henry Joyce Cancer Clinic ID 152738 - Nashville, Tennessee 944.2 miles None None None
Henry Joyce Cancer Clinic ID 152738 - Nashville, Tennessee 944.2 miles None None None
Washington University School of Medicine ID 153671 - Saint Louis, Missouri 1,039.5 miles None None None
Washington University School of Medicine ID 153671 - Saint Louis, Missouri 1,039.5 miles None None None
Washington University School of Medicine ID 153671 - Saint Louis, Missouri 1,039.5 miles None None None
Washington University School of Medicine ID 153671 - Saint Louis, Missouri 1,039.5 miles None None None
Washington University School of Medicine ID 153671 - Saint Louis, Missouri 1,039.5 miles None None None
Univ TX MD Anderson Cancer Ctr ID 153809 - Houston, Texas 1,609.9 miles None None None
Univ TX MD Anderson Cancer Ctr ID 153809 - Houston, Texas 1,609.9 miles None None None
Univ TX MD Anderson Cancer Ctr ID 153809 - Houston, Texas 1,609.9 miles None None None
Univ TX MD Anderson Cancer Ctr ID 153809 - Houston, Texas 1,609.9 miles None None None
Univ TX MD Anderson Cancer Ctr ID 153809 - Houston, Texas 1,609.9 miles None None None
Oregon Health Science University OHSU ID 152734 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 152734 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 152734 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 152734 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 152734 - Portland, Oregon 2,538.3 miles None None None

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.