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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib + CAR T-cell Therapy for B-Cell Lymphoma
Phase 1 & 2
Recruiting
Led By Ajay Gopal
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, and indolent (grade 1-3a) FL
Creatine clearance (CrCl) > 50 mL/min or serum creatinine =< 2.5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights
Study Summary
This trial is testing the safety of a new combination therapy for B-cell lymphoma. The treatment involves acalabrutinib, which may stop the growth of tumor cells, and axicabtagene ciloleucel, which is an immunotherapy that targets a specific surface antigen on lymphoma cells.
Who is the study for?
Adults with B-cell lymphoma eligible for axi-cel per FDA, understanding and consenting to the study, ECOG status of 0-1, adequate organ function, no active infections or second cancers needing treatment. Excludes those intolerant to acalabrutinib, with brain metastases or cerebrospinal fluid malignant cells, on strong CYP3A inhibitors/inducers, refractory to BTK inhibition, low blood counts, pregnant/breastfeeding women.Check my eligibility
What is being tested?
The trial is testing the combination of acalabrutinib (a drug that blocks tumor growth pathways) and axicabtagene ciloleucel (a CAR T-cell therapy targeting lymphoma cells). It aims to see if acalabrutinib can boost the effectiveness of the immunotherapy in treating B-cell lymphoma.See study design
What are the potential side effects?
Potential side effects include immune system reactions due to CAR T-cell therapy such as fever and difficulty breathing; acalabrutinib may cause bleeding issues or heart rhythm problems. Side effects vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of large B-cell lymphoma.
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My kidney function is good, with a creatinine clearance over 50 mL/min or serum creatinine <= 2.5.
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I breathe well with minimal shortness of breath and my oxygen level is above 92% without assistance.
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I meet the FDA requirements for axi-cel treatment.
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I am HIV positive and do not have any uncontrolled infections.
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My heart pumps well and I don't have fluid around it.
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I can understand and sign the consent form.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I am HIV positive without any current severe infections needing antibiotics.
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I am HIV positive with a hemoglobin level above 8.0 g/dl.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Complete response rate following chimeric antigen receptor T-cells therapy (CART)
Overall survival
Progression-free survival
+1 moreSide effects data
From 2020 Phase 2 trial • 177 Patients • NCT043461992%
Headache
1%
Chronic obstructive pulmonary disease
1%
Septic shock
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (acalabrutinib, axicabtagene ciloleucel)Experimental Treatment2 Interventions
Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2050
Axicabtagene Ciloleucel
2015
Completed Phase 2
~490
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,716 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,612,809 Total Patients Enrolled
Ajay GopalPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
14 Previous Clinical Trials
483 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious infections that would make treatment risky.I have not had major surgery in the last 7 days or have fully recovered from it.I have been diagnosed with a specific type of large B-cell lymphoma.I have or had cancer cells in my brain or spinal fluid.I cannot swallow pills or have a condition affecting my stomach or intestines that impacts how I absorb medication.My kidney function is good, with a creatinine clearance over 50 mL/min or serum creatinine <= 2.5.I breathe well with minimal shortness of breath and my oxygen level is above 92% without assistance.I have a history of seizures, stroke, memory disorders, or autoimmune diseases affecting my brain.I do not have active hepatitis B as confirmed by negative tests.I meet the FDA requirements for axi-cel treatment.I am HIV positive and do not have any uncontrolled infections.You cannot tolerate acalabrutinib (a specific medication).I do not have active bleeding or a history of bleeding disorders like hemophilia.My heart pumps well and I don't have fluid around it.I need medication for stomach acid like omeprazole.I can understand and sign the consent form.I have another cancer that needs treatment, but it's approved by the study leader.My condition did not improve with BTK inhibitor treatment.I have not had a stroke or brain bleed in the last 6 months.I am 18 years old or older.I haven't taken strong CYP3A drugs in the last week and don't need them now.I do not have serious heart problems or recent heart attacks.I am fully active or can carry out light work.I agree to use effective birth control during and for 4 months after my treatment.I am HIV positive, on ART for over 4 weeks, and may need to adjust my medication for the study.I am HIV positive without any current severe infections needing antibiotics.I am HIV positive with a hemoglobin level above 8.0 g/dl.I have uncontrolled AIHA or ITP.I have taken warfarin or similar blood thinners within the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (acalabrutinib, axicabtagene ciloleucel)
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.
Can you provide any insight into prior experiments that explored Acalabrutinib?
"Presently, there are 120 Acalabrutinib studies being conducted with 15 of them at Phase 3. Most investigations are centered around Tampa in Florida, yet clinical trials for the medication can be found across 9096 sites globally."
Answered by AI
Does this research endeavor hold any precedent?
"Acalabrutinib has accrued 120 active clinical trials spanning 49 countries and 1222 cities. The first ever trial of the drug, conducted by Baxter Healthcare Corporation in 2007, involved 4640 patients and got as far as Phase 4 approval stages before completion. Since then, 62 additional experiments have been finished."
Answered by AI
Is this medical experiment actively seeking participants?
"The records found on clinicaltrials.gov indicate that this trial is currently enrolling individuals to participate in the study. This medical research was initially uploaded onto the website on December 2nd 2020 and its information was recently updated on September 7th 2022."
Answered by AI
How many individuals have been recruited for this clinical trial thus far?
"Affirmative. The information hosted on clinicaltrials.gov attests that this medical study is presently recruiting participants; the trial was posted for the first time on December 2nd 2020 and updated most recently on September 7th 2022, with 50 patients sought from a single site."
Answered by AI
What medical conditions may be treated using Acalabrutinib?
"Acalabrutinib has shown efficacy in treating b-cell lymphomas, providing patients with amino acid supplementation, and decreasing symptoms of acute coryza."
Answered by AI
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