Ibrutinib +/− Rituximab for Chronic Lymphocytic Leukemia

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Kinase inhibitors, Coumadin

Disqualifiers: Pregnancy, Severe infection, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 60

Duration: Up to 24 cycles (96 weeks)

66 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies ibrutinib with or without rituximab in treating patients with chronic lymphocytic leukemia that has come back after treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether ibrutinib is more effective with or without rituximab in treating chronic lymphocytic leukemia.

Research Team

Jan A. Burger

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults over 18 with relapsed chronic lymphocytic leukemia who need treatment. They must be willing to use effective birth control and have no major health issues or recent treatments that could interfere. People with certain heart diseases, uncontrolled infections, bleeding disorders, or those pregnant/breastfeeding can't join.

Inclusion Criteria

I agree to use effective birth control during and 30 days after the study.

I haven't had cancer (except certain skin, cervix, or breast cancers) in the last 3 years.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

Investigational agent received within 30 days prior to the first dose of study drug

I haven't had cancer treatments like chemotherapy or immunotherapy in the last 21 days.

I haven't had major surgery or a serious injury in the last 28 days and don't expect to need major surgery during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive ibrutinib orally once daily on days 1-28 of each cycle. In Arm II, patients also receive rituximab intravenously on specified days.

Up to 24 cycles (96 weeks)

Multiple visits per cycle for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

5 years

Follow-up at 60 days, then every 4 months

Treatment Details

Interventions

• Ibrutinib
• Rituximab

Trial Overview The study is testing the effectiveness of Ibrutinib alone versus combined with Rituximab in patients whose chronic lymphocytic leukemia has returned after treatment. It aims to see if adding an immunotherapy agent (Rituximab) improves outcomes compared to just using a cell growth blocker (Ibrutinib).

Participant Groups

Group I: Arm II (ibrutinib, rituximab) Experimental Treatment 4 Interventions

Patients receive ibrutinib as in Arm I beginning on day 1 or 2. Patients also receive rituximab IV over 3-8 hours on days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 2-6. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (ibrutinib) Experimental Treatment 3 Interventions

Patients receive ibrutinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma
• Graft-versus-host disease

Approved in United States as Imbruvica for:

• Chronic lymphocytic leukemia/small lymphocytic lymphoma
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma
• Graft-versus-host disease

Approved in Canada as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma

Approved in Japan as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+