Rituximab + Bendamustine/Ibrutinib for Chronic Lymphocytic Leukemia

Recruiting at 1050 trial locations

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as bendamustine hydrochloride, 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. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether rituximab with bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.

Research Team

Jennifer A Woyach

Principal Investigator

Alliance for Clinical Trials in Oncology

Eligibility Criteria

This trial is for older patients (65+) with untreated chronic lymphocytic leukemia who meet specific diagnostic criteria, have a certain level of physical fitness (ECOG 0-2), and organ function. They must not have had prior CLL treatment except for steroids or rituximab for autoimmune complications, no major surgery within 10 days before enrollment, and no active hepatitis B or uncontrolled infections.

Inclusion Criteria

My CLL cells show specific markers and lack a certain genetic change.

My CLL is at an intermediate or high-risk stage.

My condition is at an intermediate stage with enlarged lymph nodes and possibly an enlarged liver or spleen.

Exclusion Criteria

I take 20 mg or less of prednisone or its equivalent daily.

I am not currently on blood thinners like heparin or warfarin.

You should not have a known allergy to mannitol.

Treatment Details

Interventions

• Bendamustine Hydrochloride (Alkylating agents)
• Ibrutinib (Kinase Inhibitor)
• Rituximab (Monoclonal Antibodies)

Trial Overview The study compares the effectiveness of rituximab combined with bendamustine hydrochloride or ibrutinib versus using just ibrutinib alone in treating CLL. It aims to determine which therapy works best at stopping cancer cell growth by either killing cells, preventing division, or blocking enzymes needed for cell growth.

Participant Groups

Group I: Arm III (ibrutinib, rituximab) Experimental Treatment 8 Interventions

Patients receive ibrutinib as in Arm II. Patients receive rituximab IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow aspiration and biopsy, blood sample collection, and CT throughout the study.

Group II: Arm II (ibrutinib) Experimental Treatment 7 Interventions

Patients receive ibrutinib PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow aspiration and biopsy, blood sample collection, and CT throughout the study.

Group III: Arm I (rituximab, bendamustine hydrochloride) Active Control 8 Interventions

Patients receive rituximab IV on day 1 (day 0 course 1) and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II. Additionally, patients undergo bone marrow aspiration and biopsy, blood sample collection, and CT throughout the study.

Bendamustine Hydrochloride is already approved in Japan for the following indications:

Approved in Japan as Ribomustin for:

• Chronic lymphocytic leukemia (CLL)
• Non-Hodgkin lymphoma (NHL)

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+