IRB #

STUDY00017577

Title

A Phase 1/1b/2a, 3-Part, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of AZD5991 Monotherapy and in Combination with Venetoclax in Subjects with Relapsed or Refractory Hematologic Malignancies

Principal Investigator

Uma Borate

Study Purpose

The purpose of this study is to find out the effects, both good and bad, when an investigational drug called AZD5991 is given to participants with relapsed or refractory blood cell cancers. In addition, this study will help to understand how well the study drug is taken up by the body (pharmacokinetics) and to identify biomarkers (in this case, specific proteins or enzymes made by the body). Biomarker information will be used to find out how the study drug might work and who will benefit most from treatment.

Medical Condition(s)

- Non-Hodgkin lymphoma
- Richter syndrome
- Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
- T-cell lymphoma
- Multiple myeloma (MM)
- Acute myeloid leukemia (AML)
- Myelodysplastic syndrome (MDS)

Eligibility Criteria

- Men and women 18 to 85 years of age, inclusive
- Must be diagnosed with non-Hodgkin lymphoma, Richter syndrome, CLL/small lymphocytic lymphoma (SLL), T-cell lymphoma, multiple myeloma (MM), acute myeloid leukemia (AML), or myelodysplastic syndrome (MDS)
- You must have been treated with at least 2 prior lines of therapy, and your disease is now growing
- No standard of care exists for your current condition

Age Range

18 - 85

Healthy Volunteers Needed

No

Duration of Participation

You will receive the study drug for up to 8.5 months. If you would like to continue study drug longer, you can discuss that choice further with the investigator. After you finish study treatment, your doctor will continue to watch you for side effects and follow your condition long-term.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

AstraZeneca, AB

Recruitment End

03/01/2022

Compensation Provided

No


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