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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response (CR) Rate After Induction (Six Cycles)
Secondary outcome measures
Overall Response Rate (ORR)
Other outcome measures
Gene expression/mutation profiles
Minimal residual disease
T-cell populations
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
~2050
Umbralisib
2015
Completed Phase 2
~60
Ublituximab
2017
Completed Phase 3
~2090
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,648 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,429 Total Patients Enrolled
Alexey V DanilovPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
122 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chronic hepatitis B, C, or CMV but meet specific testing criteria.I had cancer before, but it's been treated and inactive for over 2 years, or it was a minor skin cancer or in situ carcinoma without current signs of disease.I need treatment with a strong medication that affects liver enzymes.I do not have any severe illnesses or infections needing antibiotics.My kidneys are working well enough, as shown by a test.I agree to use effective birth control or abstain from sex during and after the study.I haven't had live virus vaccines in the last 4 weeks and won't during treatment.My blood clotting time is normal or managed if I'm on blood thinners.I have been diagnosed with HIV.I have never had, nor do I currently have, a brain infection known as PML.I am 65 or older, or 50 and not eligible for certain cancer treatments, or 18 and older with specific genetic changes.My lymphoma has specific genetic features (CD20+, t(11;14), cyclin D1+).I have not had major surgery in the last 28 days or have fully recovered from it.I am capable of having children and have not been surgically sterilized.I have a condition that affects how my body absorbs food.I use more than 20 mg/day of corticosteroids regularly.I haven't had a stroke, heart attack, or brain bleed in the last 6 months.I am not pregnant or breastfeeding.I haven't had a platelet transfusion in the last 7 days.I haven't used growth factors within a week before my white blood cell count test, unless my low count is due to my disease.I am taking or need to take acid-reducing medication.I do not have serious heart problems like recent heart attacks or severe heart failure.My blood clotting levels are normal or managed if I'm on blood thinners.My white blood cell count is at least 500.My lymphoma has spread to my brain or spinal cord.You have had a severe allergic reaction or anaphylaxis to the study drug or any of its ingredients.I have a known bleeding disorder, like von Willebrand's or hemophilia.My white blood cell count is high enough for treatment.I have a tumor or cancer in my bone marrow that can be measured by scans.My platelet count is at least 75,000/mm^3 without bone marrow issues.I have new or worsening chest pain.I cannot swallow or keep down oral medication.I am on blood thinners like warfarin.My treatment goal is to reduce my tumor size before a stem cell transplant.I need treatment for MCL and haven't had any systemic anticancer treatments before.I have uncontrolled AIHA or ITP.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ublituximab, acalabrutinib, umbralisib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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