IRB #

STUDY00016867

Title

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)

Principal Investigator

Uma Borate

Study Purpose

This trial will study venetoclax to assess the safety and how much of the study drug is present in the body at different times, in combination with Azacitidine, in subjects who have not previously been treated for their higher-risk MDS.

Medical Condition(s)

Myelodysplastic Syndromes
MDS

Eligibility Criteria

Documented high risk MDS using IPSS criteria
Ability to care for one's self and able to move around by one's self
Must have NO prior therapy for MDS
Must be at least 18 years of age
Must not be a candidate to undergo intensive chemotherapy or allogeneic hematopoietic stem cell transplantation (HSCT)
White blood cell count must be less than or equal to 10,000/µL

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

This trial is expected to last 64 months. Survival follow-up, which could include a brief phone call, will be conducted up to five years after trial has ended.

Minors Included

No

Contact

Knight Cancer Intake Center: (503)494-7999
Clinical Trials Information Line: (503)­494-­1080 or trials@ohsu.edu

Sponsor

AbbVie, Inc.

Recruitment End

01/30/2027

Compensation Provided

No


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