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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib + Durvalumab for Central Nervous System Lymphoma
Phase 1
Recruiting
Led By Neha Mehta-Shah, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Body weight >30 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of first 12 weeks of treatment within phase i portion of study (estimated to be 14 months)
Awards & highlights
Study Summary
This trial is testing a combination of two different types of drugs to treat people with primary central nervous system lymphoma, a cancer of the lymph nodes in the brain and spinal cord. The study has enrolled three patients so far, but all three had a different type of CNS lymphoma (secondary, not primary) and they all progressed quickly despite treatment. So the study is being amended to only include patients with primary CNS lymphoma.
Who is the study for?
This trial is for adults over 18 with primary CNS lymphoma that's relapsed or resistant to treatment, or those who can't have high-dose methotrexate therapy. Participants need a certain level of white blood cells and organ function, no HIV, and must not be pregnant. They should be able to perform daily activities with little to no assistance (ECOG status 0-2). People with secondary CNS lymphoma or recent other treatments are excluded.Check my eligibility
What is being tested?
The study tests Acalabrutinib combined with Durvalumab in patients with primary central nervous system lymphoma. It aims to see if this drug combo is effective when standard therapies fail or aren't suitable. The trial was adjusted after finding the combination less effective in secondary CNS lymphoma cases.See study design
What are the potential side effects?
Possible side effects include severe neutropenia (low white blood cell count), which increases infection risk; pneumonia; worsening heart disease; and potentially others related to immune response due to Durvalumab's action on the body's checkpoint mechanisms.
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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I weigh more than 30 kilograms.
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My platelet count is healthy and I haven't had a platelet transfusion in the last week.
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My eye condition does not involve only the vitreous.
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My brain lymphoma has returned or didn't respond to treatment, and I've tried at least one therapy.
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I have had treatment directly into my spinal fluid for cancer spread to the brain or spine.
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My cancer can be measured or observed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completion of first 12 weeks of treatment within phase i portion of study (estimated to be 14 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of first 12 weeks of treatment within phase i portion of study (estimated to be 14 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safe and tolerable dose of regimen
Secondary outcome measures
Duration of response
Overall response rate (complete response (CR) + partial response (PR))
Overall survival (OS)
+2 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
3Treatment groups
Experimental Treatment
Group I: Phase I Dose Level 2: Durvalumab + AcalabruitinibExperimental Treatment2 Interventions
Acalabrutinib 200 mg twice per day by mouth on days 1-28
Durvalumab 1500 mg intravenous on day 1 of a 28 day cycle
Group II: Phase I Dose Level 1: Durvalumab + AcalabruitinibExperimental Treatment2 Interventions
Acalabrutinib 100 mg twice per day by mouth on days 1-28
Durvalumab 1500 mg intravenous on day 1 of a 28 day cycle
Group III: Expansion Cohort: Durvalumab + AcalabrutinibExperimental Treatment2 Interventions
Acalabrutinib 100 mg or 200 mg (depends on tolerable dose found in Phase I portion of study) twice per day by mouth on days 1-28
Durvalumab 1500 mg intravenous on day 1 of a 28 day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Acalabrutinib
2020
Completed Phase 2
~2050
Find a Location
Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,265 Previous Clinical Trials
288,605,261 Total Patients Enrolled
1 Trials studying Central Nervous System Lymphoma
16 Patients Enrolled for Central Nervous System Lymphoma
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,852 Total Patients Enrolled
Neha Mehta-Shah, M.D.Principal InvestigatorWashington University School of Medicine
4 Previous Clinical Trials
110 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving treatment for another cancer.I can care for myself, but my daily activities might be limited.I need more than 8 mg of dexamethasone daily for my CNS symptoms.I am 18 years old or older.I am suspected of or confirmed to have PML.I have not had brain radiation in the last 14 days.I am not taking strong drugs that affect liver enzyme CYP3A.I weigh more than 30 kilograms.I haven't had chemotherapy or targeted therapy within the last 3 weeks.My condition has returned or didn't respond to treatment, or I can't have high dose methotrexate due to other health issues.I have not received a live vaccine in the last 30 days.I have had a serious fungal infection or active tuberculosis.I have had a stem cell transplant from a donor.I cannot swallow pills.I am taking Warfarin or similar blood thinners.I have a serious gut condition that affects how I absorb pills.I have an active hepatitis B or C infection.I have been diagnosed with HIV.I do not have any severe illnesses that would make this study too risky for me.You have an autoimmune disease that requires treatment with medication throughout your body within the past two years, except for certain cases.I have a bleeding disorder or am currently experiencing active bleeding.My platelet count is healthy and I haven't had a platelet transfusion in the last week.I haven't had a significant stroke or brain bleed in the last 6 months.My eye condition does not involve only the vitreous.Your liver enzymes (ALT and AST) are not more than 2.5 times the normal limit.I am not using any cancer treatment drugs other than corticosteroids.I have had treatment for cancer in my brain or spinal cord fluid.The amount of bilirubin in your blood cannot be more than 1.5 times the normal level.I am not on any immune system suppressing drugs, with some exceptions.I am post-menopausal or not pregnant if pre-menopausal.I haven't had major surgery in the last 28 days and don't plan to have any within 2 weeks of starting the trial.I have been treated with a BTK inhibitor before.You have enough infection-fighting white blood cells (ANC) in your body, at least 1.0 x 109/L.My organs and bone marrow are working well.My brain lymphoma has returned or didn't respond to treatment, and I've tried at least one therapy.I have had treatment directly into my spinal fluid for cancer spread to the brain or spine.I am a woman who can have children and have a recent negative pregnancy test.I have previously been treated with a checkpoint inhibitor like durvalumab.My cancer can be measured or observed.Your blood's ability to clot, measured by PT, PTT, and INR, is within the normal range.My cancer can be measured or seen on scans.I need medication for stomach acid.I can care for myself but may not be able to do heavy physical work, unless my limitations are due to lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I Dose Level 1: Durvalumab + Acalabruitinib
- Group 2: Phase I Dose Level 2: Durvalumab + Acalabruitinib
- Group 3: Expansion Cohort: Durvalumab + Acalabrutinib
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.
Do we have any prior research to suggest that Acalabrutinib is effective?
"There are 62 Phase 3 trials and 410 total active studies investigating Acalabrutinib. Though several of these trials are situated in Hat Yai, Texas, there are a total of 15285 locations running these clinical trials."
Answered by AI
Is this research project looking for new participants?
"Yes, the trial is currently underway with a goal of enrolling 21 patients from a single site. The study was first posted on 4/29/2021 and was most recently edited on 8/30/2022."
Answered by AI
What therapeutics is Acalabrutinib usually used in tandem with?
"Acalabrutinib, while most commonly used for stage iii non-small cell lung cancer, can also be used to treat mantle cell lymphoma and small lymphocytic lymphoma."
Answered by AI
Has the FDA greenlit Acalabrutinib for public consumption?
"Acalabrutinib's safety was estimated to be a 1 by our team at Power. This is due to it being in Phase 1 of clinical trials, where there is limited data supporting both safety and efficacy."
Answered by AI
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