Myelodysplastic Syndrome Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

129

Study ID:

NCT02942290

Recruitment Status:

Active, not recruiting

Sponsor:

AbbVie

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There are 37 Locations for this study

See Locations Near You

University of Arizona Cancer Center - North Campus /ID# 154155
Tucson Arizona, 85719, United States
The University of Chicago Medical Center /ID# 153673
Chicago Illinois, 60637, United States
Univ Maryland School Medicine /ID# 153669
Baltimore Maryland, 21201, United States
Tufts Medical Center /ID# 153672
Boston Massachusetts, 02111, United States
Dana-Farber Cancer Institute /ID# 152735
Boston Massachusetts, 02215, United States
Washington University-School of Medicine /ID# 153671
Saint Louis Missouri, 63110, United States
Columbia University Medical Center /ID# 153661
New York New York, 10032, United States
Weill Cornell Medical College /ID# 155524
New York New York, 10065, United States
Oregon Health and Science University /ID# 152734
Portland Oregon, 97239, United States
University of Pittsburgh MC /ID# 153662
Pittsburgh Pennsylvania, 15260, United States
Tennessee Oncology-Nashville Centennial /ID# 222769
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center /ID# 152738
Nashville Tennessee, 37232, United States
UT MD Anderson Cancer Center /ID# 153809
Houston Texas, 77030, United States
Concord Repatriation General Hospital /ID# 154958
Concord New South Wales, 2139, Australia
Duplicate_St. Vincent's Hospital, Darlinghurst /ID# 222846
Darlinghurst New South Wales, 2010, Australia
St George Hospital /ID# 154954
Kogarah New South Wales, 2217, Australia
Liverpool Hospital /ID# 222410
Liverpool New South Wales, 2170, Australia
Calvary Mater Newcastle /ID# 154957
Waratah New South Wales, 2298, Australia
Princess Alexandra Hospital /ID# 154990
Woolloongabba Queensland, 4102, Australia
Austin Health /ID# 154955
Heidelberg Victoria, 3084, Australia
Alfred Health /ID# 154956
Melbourne Victoria, 3004, Australia
Fiona Stanley Hospital /ID# 222847
Murdoch Western Australia, 6150, Australia
Juravinski Cancer Centre /ID# 152947
Hamilton Ontario, L8V 1, Canada
CHU de Nantes, Hotel Dieu -HME /ID# 153828
Nantes Pays-de-la-Loire, 44000, France
AP-HP - Hopital Saint-Louis /ID# 153827
Paris , 75010, France
Universitatsklinikum Mannheim /ID# 153140
Mannheim Baden-Wuerttemberg, 68167, Germany
Universitaetsklinikum Koeln /ID# 153141
Köln Nordrhein-Westfalen, 50937, Germany
Duplicate_Universitaetsklinikum Carl Gus /ID# 153958
Dresden Sachsen, 01307, Germany
Universitaetsklinikum Leipzig /ID# 153142
Leipzig Sachsen, 04103, Germany
Universitaetsklinikum Halle (Saale) /ID# 153760
Halle (Saale) , 06120, Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 153139
Munich , 81675, Germany
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 153764
Rome Lazio, 00161, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 153763
Bologna , 40138, Italy
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 156492
Norwich Norfolk, NR4 7, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 222567
Oxford Oxfordshire, OX3 9, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 158810
Birmingham , B15 2, United Kingdom
King's College Hospital NHS Foundation Trust /ID# 156489
London , SE5 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

129

Study ID:

NCT02942290

Recruitment Status:

Active, not recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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