A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Participants With Relapsed/Refractory Myelodysplastic Syndromes (MDS)
NCT ID: NCT02966782
Last Updated: 2023-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
70 participants
INTERVENTIONAL
2017-03-07
2023-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Venetoclax monotherapy (Cohort 1)
venetoclax
Tablet
Venetoclax + azacitidine (Cohort 2)
venetoclax
Tablet
azacitidine
Powder for injection, subcutaneously or intravenous
Safety Expansion (Cohort 3)
venetoclax
Tablet
azacitidine
Powder for injection, subcutaneously or intravenous
Interventions
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venetoclax
Tablet
azacitidine
Powder for injection, subcutaneously or intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject enrolled in venetoclax monotherapy must have documented failure of prior therapy with a hypomethylating agent (HMA). HMA-failure is defined as:
1. Relapse after initial complete or partial response or hematological improvement after at least 4 cycles of azacitidine or at least 4 cycles of decitabine within the last 5 years, OR
2. Failure to achieve complete or partial response or hematological improvement after at least 4 cycles of azacitidine or at least 4 cycles of decitabine within the last 5 years
* Subjects must have presence of \< 20% bone marrow blasts per bone marrow biopsy/aspirate at screening.
* Subject is not a candidate to undergo allogenic hematopoietic stem cell transplantation (HSCT).
* Subject must have an Eastern Cooperative Oncology Group (ECOG) performance score of ≤2.
* Subject must have adequate hematologic, renal, and hepatic function.
Exclusion Criteria
* Subject has MDS evolving from a pre-existing myeloproliferative neoplasm (MPN).
* Subject has MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
* Subject has received allogeneic HSCT or solid organ transplantation.
* Subject has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug.
* Subject is pregnant or breastfeeding.
18 Years
ALL
No
Sponsors
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Celgene; Genentech, Inc.
UNKNOWN
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Arizona Cancer Center - North Campus /ID# 157503
Tucson, Arizona, United States
University of Colorado Hospital /ID# 155365
Aurora, Colorado, United States
Yale University /ID# 162544
New Haven, Connecticut, United States
Duplicate_University of Chicago /ID# 155364
Chicago, Illinois, United States
Pediatric Endocrine Associates /ID# 171227
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 155361
Boston, Massachusetts, United States
University of Massachusetts - Worcester /ID# 155366
Worcester, Massachusetts, United States
Columbia Univ Medical Center /ID# 156388
New York, New York, United States
Oregon Health and Science University /ID# 155360
Portland, Oregon, United States
University of Texas MD Anderson Cancer Center /ID# 155362
Houston, Texas, United States
St George Hospital /ID# 156037
Kogarah, New South Wales, Australia
Liverpool Hospital /ID# 155952
Liverpool, New South Wales, Australia
St Vincent's Hospital Melbourne /ID# 155950
Fitzroy Melbourne, Victoria, Australia
The Royal Melbourne Hospital /ID# 155949
Parkville, Victoria, Australia
Royal Perth Hospital /ID# 155951
Perth, Western Australia, Australia
Universitatsklinikum Mannheim /ID# 156038
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Koeln /ID# 155519
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Duesseldorf /ID# 154899
Düsseldorf, North Rhine-Westphalia, Germany
Marien Hospital Duesseldorf /ID# 155518
Düsseldorf, North Rhine-Westphalia, Germany
Universitaetsklinikum Leipzig /ID# 154897
Leipzig, Saxony, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 154898
Dresden, , Germany
Universitaetsklinikum Halle (Saale) /ID# 158643
Halle, , Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 154896
Munich, , Germany
Countries
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References
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Zeidan AM, Borate U, Pollyea DA, Brunner AM, Roncolato F, Garcia JS, Filshie R, Odenike O, Watson AM, Krishnadasan R, Bajel A, Naqvi K, Zha J, Cheng WH, Zhou Y, Hoffman D, Harb JG, Potluri J, Garcia-Manero G. A phase 1b study of venetoclax and azacitidine combination in patients with relapsed or refractory myelodysplastic syndromes. Am J Hematol. 2023 Feb;98(2):272-281. doi: 10.1002/ajh.26771. Epub 2022 Nov 10.
Franke GN, Luckemeier P, Platzbecker U. Allogeneic Stem-Cell Transplantation in Patients With Myelodysplastic Syndromes and Prevention of Relapse. Clin Lymphoma Myeloma Leuk. 2021 Jan;21(1):1-7. doi: 10.1016/j.clml.2020.10.008. Epub 2020 Oct 16.
Other Identifiers
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2016-001904-46
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-522
Identifier Type: -
Identifier Source: org_study_id
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