IRB #

STUDY00015136

Title

A Phase 1B Dose Escalation and Dose Expansion Study of ONO/GS-4059 in Combination with Other Targeted Anti-cancer Therapies in Subjects with B-cell Malignancies

Principal Investigator

Alexey Danilov

Study Purpose

The purpose of this study is to find out what side effects good and/or bad are associated with the investigational drug ONO/GS-4059, as well as to determine a tolerable dosage, when combined with either idelalisib or entospletinib in treating B-cell malignancies such as Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Follicular Lymphoma, Non-germinal Center B-cell-like Diffuse Large B Cell Lymphoma.

Medical Condition(s)

Previously treated:

Chronic Lymphocytic Leukemia (CLL)
Mantle Cell Lymphoma (MCL)
Follicular Lymphoma (FL)
Marginal Zone Lymphoma (MZL)
Small Lymphocytic Lymphoma (SLL)
Waldenstrom's Macroglobulinemia (WM)
Non-germinal Center B-cell-like Diffuse Large B Cell Lymphoma (non-GCB DLBCL)

Eligibility Criteria

Male or Female at least 18 years or older

Prior treatment for FL, MZL, CLL, SLL, MCL, WM, or non-GCB DLBCL with one or more prior chemotherapy-based or immunotherapy-based regimen who are not transplant eligible and have had either documented disease progression or no response to the most recent treatment regimen

No history of Richter's transformation

No history of myelodysplastic syndrome

Not infected with HIV

Not pregnant or breastfeeding

No history of stroke

Age Range

18 - 105

Healthy Volunteers Needed

No

Duration of Participation

36 month long participation with a 30 day follow up

Minors Included

No

Contact

Knight Clinical Trial information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Gilead Sciences, Inc.

Recruitment End

01/01/2030

Compensation Provided

No


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