Acalabrutinib + Rituximab for Mantle Cell Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByLuhua (Michael) Wang

Age: 65+

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

Trial Summary

What is the purpose of this trial?This phase II trial studies the side effects of acalabrutinib and rituximab and its effect in treating patients with previously untreated mantle cell lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that binds to a protein called CD20, which is found on B-cells, and may kill cancer cells. Giving acalabrutinib and rituximab may help to control mantle cell lymphoma in elderly patients.

Eligibility Criteria

This trial is for people aged 65 or older with newly diagnosed mantle cell lymphoma, which has specific biological markers. They must be able to swallow pills, have no major health issues that could interfere with the study, and not be on certain medications. Participants need normal organ function and controlled cardiovascular conditions. Pregnant women or those unable to use effective birth control are excluded.

Inclusion Criteria

My kidney and liver functions are within the required range.

I am 65 or older with newly diagnosed mantle cell lymphoma and have not received any treatment.

Exclusion Criteria

I have had a stroke in the last 6 months.

I haven't had any recent bleeding disorders or strokes.

I do not have significant heart issues or uncontrolled serious conditions.

I have been taking more than 20 mg of steroids daily for over 2 weeks.

I need to take warfarin or a similar drug for blood thinning.

I have severe stomach or bowel problems that affect my ability to absorb medications.

I have uncontrolled AIHA or ITP.

I do not have any ongoing serious infections.

I do not have brain involvement with my lymphoma or a condition called PML.

I have previously been treated with acalabrutinib or for mantle cell lymphoma.

I need medication that strongly affects liver enzymes.

I have or had progressive brain infection (PML).

I haven't had major surgery in the last 30 days or have fully recovered if I did.

Participant Groups

The trial is testing the combination of acalabrutinib (a drug that blocks enzymes needed for cancer cell growth) and rituximab (an antibody targeting B-cells). It aims to see how well this combo works in treating elderly patients who haven't had any previous treatments for their mantle cell lymphoma.

1Treatment groups

Experimental Treatment

Group I: Treatment (acalabrutinib, rituximab)Experimental Treatment2 Interventions

Patients receive acalabrutinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV over 3-4 hours on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2-12, 14, 18, 20, 22, and 24. Cycles repeats every 28 days for up to 24 months or until complete remission is achieved in the absence of disease progression or unacceptable toxicity.

Acalabrutinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Calquence for: