Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia

  • STATUS
    Recruiting
  • End date
    Oct 31, 2025
  • participants needed
    720
  • sponsor
    National Cancer Institute (NCI)
Updated on 12 May 2021
Investigator
Site Public Contact
Primary Contact
MercyOne Waterloo Medical Center (1.5 mi away) Contact
+736 other location
fever
cancer
corticosteroids
lymphoid leukemia
anemia
chronic lymphocytic leukemia
lymphoma
monoclonal antibodies
antiretroviral agents
direct bilirubin
fatigue
gilbert's syndrome
thrombocytopenia
venetoclax
hormone therapy
chemotherapy drugs
monoclonal protein
immunoglobulin
ibrutinib
btk inhibitor
lymphadenopathy
night sweats
lymphocytosis
obinutuzumab
cyclin d1

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. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ibrutinib, obinutuzumab, and venetoclax may work better than giving ibrutinib and obinutuzumab in treating patients with chronic lymphocytic leukemia.

Description

PRIMARY OBJECTIVE:

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. III. Compare minimal residual disease (MRD) status as assessed by flow cytometry at baseline and then sequentially during treatment of the two treatment arms.

IV. Collect baseline and response evaluation (after cycle 19) bone marrow and paired blood specimens for evaluation of MRD.

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 progression-free survival (PFS).

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 cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax PO once daily (QD) on days 1-28 of cycles 3-14. Treatment repeats every 28 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive ibrutinib PO and obinutuzumab as in arm A. Cycles 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.

Details
Condition Chronic Lymphocytic Leukemia, Lymphocytic Leukemia, Chronic, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, CCND1/IGHG1 Fusion Negative, t(11;14) Negative, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, b-cell small lymphocytic lymphoma
Treatment quality-of-life assessment, Ibrutinib, Obinutuzumab, venetoclax
Clinical Study IdentifierNCT03701282
SponsorNational Cancer Institute (NCI)
Last Modified on12 May 2021

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