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Kinase Inhibitor
Acalabrutinib + Obinutuzumab + Glofitamab for Mantle Cell Lymphoma
Phase 2
Recruiting
Led By John H Baird
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
Age: >= 18 years
Histologically confirmed diagnosis of mantle cell lymphoma according to the World Health Organization (WHO) classification
Must not have
Prior exposure to a BTK inhibitor (including but not limited to ibrutinib, ac
Prior treatment with a T-cell engaging bispecific antibody
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years from start of treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combo of drugs to treat relapsed/refractory mantle cell lymphoma. It may help the body's immune system attack cancer and stop cancer cells from growing.
Who is the study for?
This trial is for adults with mantle cell lymphoma that has returned or didn't respond to previous treatments. Participants must be in fairly good health, have a certain level of blood counts and organ function, and agree to use effective birth control. People can't join if they've had certain recent cancer treatments, used T-cell engaging bispecific antibodies before, or been exposed to BTK inhibitors like ibrutinib.
What is being tested?
The trial tests the combination of acalabrutinib (a kinase inhibitor), obinutuzumab (a monoclonal antibody), and glofitamab (a bispecific antibody) on patients with relapsed/refractory mantle cell lymphoma. It aims to see how well these drugs work together and what side effects they might cause.
What are the potential side effects?
Potential side effects include reactions related to the immune system such as infusion reactions, low blood counts leading to increased infection risk or bleeding problems, liver enzyme changes suggesting liver impact, fatigue, and possibly heart issues due to the stress on the body's systems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My lymphoma is confirmed as mantle cell type.
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My white blood cell count is healthy, or I have bone marrow involvement.
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My kidney function, measured by creatinine levels or clearance, is normal.
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My tumor is CD20 positive after my latest treatment.
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My platelet count is above 75,000/mm^3 without bone marrow involvement or above 30,000/mm^3 with it.
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My condition worsened or didn't improve after at least one treatment.
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I have recovered from side effects of cancer treatment, except for hair loss.
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I am a woman who can have children and my pregnancy test is negative.
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My blood clotting measurements are within safe limits.
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I am able to get out of my bed or chair and move around.
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My hemoglobin level is at least 8 g/dL, unless it's low because of my illness.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously been treated with a BTK inhibitor.
Select...
I have been treated with a bispecific antibody before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years from start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years from start of treatment
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 (phase 2)
Incidence of unacceptable adverse events (AEs) (safety lead-in)
Secondary study objectives
Duration of response
Incidence of AEs
Minimal residual disease (MRD) negatively rate
+4 moreAwards & 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 (acalabrutinib, obinutuzumab, glofitamab)Experimental Treatment9 Interventions
Patients recieve acalabrutinib PO BID of each cycle, obinutuzumab IV on days 1 and 7 of cycle 1 only, and glofitamab IV over 2-4 hours on days 8 and 15 of cycle 1 and day 1 of each subsequent cycle. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients with MRD positive CR, PR, or SD after 12 cycles of protocol therapy may continue receiving single agent acalabrutinib per standard of care during the follow-up phase of the study. Patients also undergo a ECHO or MUGA during screening, as well as PET/CT or CT, and blood specimen collection throughout the trial. Patients may also undergo bone marrow biopsies throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glofitamab
2021
Completed Phase 1
~60
Computed Tomography
2017
Completed Phase 2
~2790
Acalabrutinib
2020
Completed Phase 2
~2080
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Biospecimen Collection
2004
Completed Phase 3
~2030
Echocardiography
2013
Completed Phase 4
~11580
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Obinutuzumab
2014
Completed Phase 3
~3470
Positron Emission Tomography
2011
Completed Phase 2
~2200
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,540 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,099 Total Patients Enrolled
John H BairdPrincipal InvestigatorCity of Hope Medical Center
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