Ibrutinib for Chronic Lymphocytic Leukemia

(MERIT Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Sikander Ailawadhi

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects and how well ibrutinib works in treating patients with chronic lymphocytic leukemia who responded to initial treatment used to reduce a cancer (front-line therapy) but have residual disease. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Research Team

Sikander Ailawadhi

Principal Investigator

Mayo Clinic

Asher Chanan-Khan, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for patients with chronic lymphocytic leukemia (CLL) who have had some response to initial cancer treatment but still have residual disease. They must understand the study and consent, not be nursing or pregnant, and can't join if they've had certain other cancers, are MRD-negative after frontline therapy, need strong CYP3A modulators, or have serious liver impairment.

Inclusion Criteria

Understand and voluntarily sign an informed consent form

I've completed at least 2 cycles of initial treatment for CLL and responded to it, but haven't had ibrutinib.

I have a type of leukemia and still have some cancer cells despite treatment.

Exclusion Criteria

I am of childbearing age and do not plan to use birth control.

I haven't used any experimental drugs in the last 28 days, except for low dose prednisone.

You have other health conditions that could make it unsafe for you to take ibrutinib, such as HIV infection or bleeding disorders.

Treatment Details

Interventions

• Ibrutinib (Kinase Inhibitor)

Trial Overview The trial tests Ibrutinib's effectiveness in treating minimal residual disease in CLL patients post front-line therapy. It aims to see if Ibrutinib can halt cancer growth by inhibiting enzymes needed for cell proliferation. Participants will also provide samples for laboratory biomarker analysis.

Participant Groups

Group I: Treatment (ibrutinib) Experimental Treatment 2 Interventions

Patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 4 weeks\* for up to 36 courses in the absence of disease progression or unacceptable toxicity. Note: \*The last course may last up to 56 days to accommodate the study drug discontinuation visit.

Ibrutinib is already approved in Canada, Japan for the following indications:

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?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School