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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Umbralisib + Ublituximab for Mantle Cell Lymphoma

Phase 2

Waitlist Available

Led By Alexey V Danilov

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Creatinine clearance of >= 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula

Histologically confirmed mantle cell lymphoma with documentation of monoclonal CD20+ B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1

Must not have

Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer

Clinically significant uncontrolled illness, including active infection requiring antibiotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies drugs to see if they can stop the growth of mantle cell lymphoma cells.

Who is the study for?

This trial is for adults with previously untreated mantle cell lymphoma who are fit enough to undergo treatment and have not had certain other cancers or major surgery recently. They must be able to use effective birth control, have adequate organ function, and cannot be on strong CYP3A4 inhibitors or proton pump inhibitors.

What is being tested?

The study tests a combination of acalabrutinib, umbralisib, and ublituximab in treating mantle cell lymphoma. These drugs may block enzymes that cancer cells need to grow and could prevent the spread of cancer by targeting specific proteins on the cells.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response to these drugs, possible liver enzyme changes, fatigue, digestive issues like nausea or diarrhea, increased risk of infection due to weakened immunity, and blood-related problems such as anemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys are working well enough, as shown by a test.

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My lymphoma has specific genetic features (CD20+, t(11;14), cyclin D1+).

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My blood clotting time is normal or managed if I'm on blood thinners.

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My blood clotting levels are normal or managed if I'm on blood thinners.

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My white blood cell count is at least 500.

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My white blood cell count is high enough for treatment.

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I have a tumor or cancer in my bone marrow that can be measured by scans.

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My platelet count is at least 75,000/mm^3 without bone marrow issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need treatment with a strong medication that affects liver enzymes.

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I do not have any severe illnesses or infections needing antibiotics.

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I haven't had live virus vaccines in the last 4 weeks and won't during treatment.

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I have been diagnosed with HIV.

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I have never had, nor do I currently have, a brain infection known as PML.

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I have not had major surgery in the last 28 days or have fully recovered from it.

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I have a condition that affects how my body absorbs food.

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I use more than 20 mg/day of corticosteroids regularly.

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I am not pregnant or breastfeeding.

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My lymphoma has spread to my brain or spinal cord.

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I have a known bleeding disorder, like von Willebrand's or hemophilia.

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I have new or worsening chest pain.

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I cannot swallow or keep down oral medication.

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I am on blood thinners like warfarin.

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My treatment goal is to reduce my tumor size before a stem cell transplant.

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I have uncontrolled AIHA or ITP.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Response (CR) Rate After Induction (Six Cycles)

Secondary study objectives

Overall Response Rate (ORR)

Other study objectives

Gene expression/mutation profiles

Minimal residual disease

T-cell populations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ublituximab, acalabrutinib, umbralisib)Experimental Treatment3 Interventions

Patients receive ublituximab IV over 90 minutes-4 hours on days 1, 8, and 15 of cycle 1 and days 1 of cycles 2-6. Patients also receive acalabrutinib PO BID and umbralisib PO QD on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive ublituximab IV on day 1 on cycles 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30. Patients also receive acalabrutinib Po BID and umbralisib PO QD on day 1-28. Treatment repeats every 28 days for 24 cycles in the absence of disease progression of unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2080

Ublituximab

2017

Completed Phase 3

~1490