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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)

Status
Active
Cancer Type
Leukemia
Lymphoma
Trial Phase
Phase III
Eligibility
18 - 69 Years, Male and Female
Study Type
Treatment
NCT ID
NCT03701282
Protocol IDs
EA9161 (primary)
EA9161
NCI-2018-02127
Study Sponsor
ECOG-ACRIN Cancer Research Group

Summary

This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib, obinutuzumab and venetoclax may work better in treating patients with chronic lymphocytic leukemia.

Objectives

PRIMARY OBJECTIVES:
I. To compare the progression free survival (PFS) of the time limited administration of the three-drug combination ibrutinib-obinutuzumab-venetoclax (IOV) to ibrutinib-obinutuzumab (IO) in untreated chronic lymphocytic leukemia (CLL) patients younger than 70 years of age.

SECONDARY OBJECTIVES:
I. Evaluate overall survival (OS) of patients based on treatment arm.
II. Monitor and assess toxicity of treatment based on treatment arm.

QUALITY OF LIFE (QOL) OBJECTIVES:
I. To compare quality of life (QOL) in CLL patients during the first 19 cycles of treatment among patients on each treatment arm.
II. To compare QOL over the long-term in CLL patients receiving continuous therapy using ibrutinib to that of CLL patients who completed time limited therapy.
III. Evaluate adherence to therapy for the two arms (one of which requires more intense, but shorter duration treatment, and one of which requires less intense, but indefinite duration therapy) and explore how adherence in each arm relates to treatment-free survival (TFS).

EXPLORATORY TOBACCO USE OBJECTIVES:
I. To determine the effects of tobacco, operationalized as combustible tobacco (1a), other forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported cancer-treatment toxicity (adverse events [both clinical and hematologic]) and dose modifications.
II. To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms.
III. To examine quitting behaviors and behavioral counseling/support and cessation medication utilization.
IV. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive ibrutinib orally (PO) daily on days 1-28 and obinutuzumab intravenously (IV) over 4 hours on days 1, 2, 8, and 15 of course 1 and on day 1 of courses 2-6. Patients also receive venetoclax PO once daily (QD) on days 1-28 of courses 3-14. Treatment repeats every 28 days for up to 19 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive ibrutinib PO and obinutuzumab as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

All patients, including those who discontinue therapy early, are followed for response until disease progression, even if non-protocol therapy is initiated. Patients are then followed every 3 months for first 2 years, every 6 months for years 3-5, and then every 12 months for years 6-10. All patients must also be followed through completion of all protocol therapy.

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