IRB #

STUDY00016140

Title

A Phase I/II study of Syk inhibitor entospletinib (GS-9973) in combination with obinutuzumab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and B-cell malignancies

Principal Investigator

Alexey Danilov

Study Purpose

The purpose of this study is to identify a safe and tolerable dose of entospletinib, the study drug, in combination with obinutuzumab and find out what effects, if any, this drug combination has on patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and B-cell malignancies.

Medical Condition(s)

Lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), B-cell malignancies, non-Hodgkin lymphoma, relapsed/refractory.

Eligibility Criteria

Participants must have a diagnosis of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and B-cell malignancies and be 18 years or older.

Exclusion criteria include:
- certain prior therapeutic anticancer treatments including SYK inhibitors
- chronic use of corticosteroids in excess of prednisone 30 mg/day
- stem cell transplant recipients must have no evidence of, and not received treatment
for, graft versus host disease (GVHD)
- uncontrolled immune hemolysis or thrombocytopenia
- history of HIV infection or active HCB or HCV infection
- pregnant or breastfeeding women
- participants actively receiving another investigational product

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Study drug is administered for at least 12 cycles or until disease progression or an unacceptable adverse event. If it is clinically safe to do so, and a patient is benefitting from the study drug, they may continue to receive the study drug after these 12 cycles. However, if evidence of disease, after 12 cycles of therapy, is found then study drug will be stopped. After study drug administration is finished, the investigator will continue to follow participants for side effects every 4 to 6 months until disease progression or death.

Minors Included

No

Contact

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

Sponsor

Gilead is providing study drug and funding. Genentech is providing study drug.

Recruitment End

07/14/2021

Compensation Provided

No


Go Back