IRB #

STUDY00019800

Title

[NCI CIRB] - A041702 - A RANDOMIZED PHASE III STUDY OF IBRUTINIB PLUS OBINUTUZUMAB VERSUS IBRUTINIB PLUS VENETOCLAX AND OBINUTUZUMAB IN UNTREATED OLDER PATIENTS (≥ 70 YEARS OF AGE) WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

Principal Investigator

Stephen Spurgeon

Study Purpose

The primary purpose of this study is to determine if adding a new anti-cancer drug (venetolax) to the usual treatment (ibrutinib plus obinutuzumab) better, the same as, or worse than the usual treatment alone for untreated older patients with CLL.

This study also looks at whether or not patients who have no detectable CLL after a year of receiving the usual treatment plus the new anti-cancer drug discontinue therapy.

Medical Condition(s)

CLL

Eligibility Criteria

1- CLL Diagnosis

2- Must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)

3- Completion of treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL at least 4 weeks prior to enrollment.

4- ≥ 70 years of age

5- Patients must be able to swallow capsules

6- Patients must not be receiving active systemic anticoagulation with heparin or warfarin.

7- Patients must not have a history of Richter's transformation or prolymphocytic leukemia

8- lab values within range


Age Range

70 - 100

Healthy Volunteers Needed

No

Duration of Participation

10 years from registration

Minors Included

No

Contact

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

Sponsor

Alliance

Recruitment End

04/30/2024

Compensation Provided

No


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