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



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:January 12, 2017
End Date:December 3, 2020
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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A Phase 1b Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

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.


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
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.

- Participant has received a live attenuated vaccine within 4 weeks prior to the first
dose of study drug.
We found this trial at
13
sites
660 South Euclid Avenue
Saint Louis, Missouri 63110
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Baltimore, Maryland 21201
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Baltimore, MD
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450 Brookline Avenue
Boston, Massachusetts 02211
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Boston, MA
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Boston, Massachusetts 02111
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Boston, MA
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Chicago, Illinois 60637
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Chicago, IL
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Concord,
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Houston, TX
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Nashville, Tennessee 37232
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Nashville, TN
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New York, NY
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New York, NY
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Pittsburgh, Pennsylvania 15260
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Pittsburgh, PA
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Portland, OR
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1501 North Campbell Avenue
Tucson, Arizona 85724
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Tucson, AZ
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