Ibrutinib for Mantle Cell Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByLuhua (Michael) Wang

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

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 how well ibrutinib works in treating participants with untreated high risk smoldering mental cell lymphoma. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

This trial is for adults with untreated high-risk smoldering mantle cell lymphoma (MCL) who have never received treatment, have measurable disease less than or equal to 5 cm, and are in good general health. They must be able to swallow capsules and agree to use effective birth control methods. People with blastoid or pleomorphic MCL variants, bulky tumors over 5 cm, certain heart conditions, severe liver impairment, recent major surgery or live vaccines, bleeding disorders, uncontrolled infections or other serious medical issues cannot join.

Inclusion Criteria

High risk smoldering MCL with at least one of the following eligibility criteria: Ki-67 of 15-30%, White blood cells (WBC) 15-30k, Lymph node size 3-5 cm in diameter, Complex karyotype, TP53 mutated or wild type and/or del17p (FISH% 10-50%), MYC positive MCL, Presence of KMT2D, BIRC3, NOTCH2, NSD2 mutations, Understand and sign an IRB-approved informed consent form, Age >= 18 years, ECOG performance status of 2 or less, Cardiology clearance required, Absence of cytopenia attributed to bone marrow infiltration, ANC > 1000/mm^3, Platelet count > 100,000/mm^3, AST/SGOT and ALT/SGPT < 3 x upper limit of normal or < 5 x upper limit of normal if hepatic metastases are present, Serum bilirubin < 1.5 mg/dl, Cr clearance >= 30 mL/min, Disease free of prior malignancies for >= 6 months, Willing to receive transfusions of blood products, Able to participate in all study procedures and therapy, Female subjects of non-reproductive potential or using effective birth control, Male and female subjects using highly effective birth control and a barrier method

My MCL diagnosis is confirmed with specific markers or classic signs in a biopsy.

I have never received any treatment for my condition.

Exclusion Criteria

Risk factors including clinically significant disease related symptoms, Blastoid variant histology, Pleomorphic variant histology, Ki-67 > 30%, Bulky tumors > 5 cm, CNS involvement at diagnosis, Prior treatment for mantle cell lymphoma, Prior exposure to BTK inhibitor, Pregnant or breastfeeding females, Known history of HIV, HCV, or HBV, History of central nervous system lymphoma, History of stroke or intracranial hemorrhage within 6 months, Clinically significant cardiovascular disease, Inability to swallow capsules, Concomitant anticoagulation with warfarin, Chronic liver disease meeting Child-Pugh class C, Uncontrolled active systemic infection, Major surgery within 4 weeks of first dose of study drug, Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug, Recent infection requiring systemic treatment within 14 days before the first dose of study drug, Known bleeding disorders, Unresolved toxicities from prior anticancer therapy, Concurrent systemic immunosuppressant therapy within 21 days of the first dose of study drug

I do not have any serious medical conditions that would make it unsafe for me to participate.

Participant Groups

The trial is testing the effectiveness of Ibrutinib in participants with untreated high-risk smoldering MCL. Ibrutinib is a medication that may inhibit tumor growth by blocking enzymes needed for cell growth. This phase II study aims to understand how well it works before any traditional treatment starts.

1Treatment groups

Experimental Treatment

Group I: Treatment (ibrutinib)Experimental Treatment1 Intervention

Participants receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days for 5 years 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: