A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Participants With Relapsed/Refractory Myelodysplastic Syndromes (MDS)

Completed · Phase 1

Conditions studied: Myelodysplastic Syndromes (MDS)

In brief

This is a Phase 1b, open-label, multicenter study designed to evaluate the safety and pharmacokinetics of venetoclax as a single-agent and in combination with azacitidine in participants with relapsed/refractory Myelodysplastic Syndromes (MDS).

Key facts

Study ID

NCT02966782

Run by

AbbVie

People needed

70

Starts

2017-03-07

Expected to finish

2023-04-05

Last updated by the study team

2023-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who have relapsed or refractory MDS.
• Subject enrolled in venetoclax monotherapy must have documented failure of prior therapy with a hypomethylating agent (HMA). HMA-failure is defined as:
• 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
• 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.

You may not qualify if…

• Subject has received prior therapy with a BH3 mimetic.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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