IRB #

STUDY00019708

Title

[NCI CIRB] EA9161 - A Randomized Phase III Study of the addition of Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)

Principal Investigator

Stephen Spurgeon

Study Purpose

The purpose of this study is to compare the effects, overall survival, quality of life, and approach of a time limited administration of the three drug treatment combination compared to the standard two drug treatment combination.

Medical Condition(s)

Chronic Lymphocytic Leukemia (CLL)

Eligibility Criteria

Eligibility criteria highlighted below:

1- Diagnosis of CLL
2- No prior chemotherapy, BTK inhibitor therapy, venetoclax, small molecule signaling inhibitor, or monoclonal antib-body therapy for treatment of CLL or SLL
3- Must have at least one indication of treatment
4 - greater than/equal to 18 years of age and less than 70 years of age
5- Life expectancy greater than/equal to 12 months
6- No deletion of 17p13 by FISH cytogenetic analysis
7 - lab values within range
8- No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment
9 - No current use of corticosteroids
10 - No previous autoimmune complications

Age Range

18 - 69

Healthy Volunteers Needed

No

Duration of Participation

10 years from the time of study entry.

Minors Included

No

Contact

Knight Information Line - trials@ohsu.edu or 503-494-1080

Sponsor

ECOG - ACRIN

Recruitment End

03/31/2023

Compensation Provided

No


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