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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib + Liso-Cel for B-Cell Lymphoma
Phase 2
Recruiting
Led By Connor Johnson, MD
Research Sponsored by Patrick C. Johnson, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from first response to disease progression or death up to 15 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new treatment for relapsed/refractory B-cell lymphoma to assess its effectiveness and safety.
Who is the study for?
Adults (≥18 years) with aggressive B-cell non-Hodgkin lymphoma that's come back or hasn't responded to treatment, including specific subtypes like DLBCL. Must have tried at least two prior therapies and be in good enough health for leukapheresis. Can't join if pregnant, breastfeeding, HIV positive, have active hepatitis B/C, uncontrolled infections or certain heart conditions.
What is being tested?
The trial is testing the combination of acalabrutinib (a cancer drug) with lisocabtagene maraleucel (liso-cel), a type of CAR T-cell therapy. It aims to see how safe and effective this combo is for those who've relapsed or haven’t responded well to previous treatments.
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever and fatigue, possible complications from leukapheresis procedure, liver function changes due to acalabrutinib, and risks associated with CAR T-cell therapy like cytokine release syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from first response to disease progression or death up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from first response to disease progression or death up to 15 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete response rate (CRR)
Secondary study objectives
Duration of Response
ER visit rates
Event free survival
+9 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: ACALABRUTINIB and LISOCABTAGENE MARALEUCELExperimental Treatment3 Interventions
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, as tolerated for one year
* Liso-cel
* Acalabrutinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lymphodepleting chemotherapy
2014
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Patrick C. Johnson, MDLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Jeremy Abramson, MDLead Sponsor
AstraZenecaIndustry Sponsor
4,427 Previous Clinical Trials
289,164,425 Total Patients Enrolled
Connor Johnson, MDPrincipal InvestigatorMassachusetts General Hospital
Jeremy Abramson, MD, MMScPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need medication for stomach acid.I have trouble swallowing pills or have a serious stomach or intestine condition.I am over 18 and have a specific type of aggressive B-cell lymphoma, but not primary CNS lymphoma.I had a stem cell transplant from a donor within the last 3 months.My kidneys are functioning well enough to clear waste.I have had gene therapy or adoptive T cell therapy before.I have not had a stroke or major brain event in the last 6 months.I have a significant brain or spinal cord condition.I am currently receiving treatment for another cancer.I have had heart problems in the last 6 months.I am HIV positive.I am on blood thinners or have a bleeding disorder.I need medication that strongly affects liver enzyme levels.My blood counts are normal and my lungs work well.My cancer shows up on PET scans.I have an infection that is not responding to treatment.I have not had major surgery in the last 28 days.I am willing and able to follow all study requirements.My lymphoma has not responded to at least 2 previous treatments.My heart pumps blood well and my heart's pumping ability is at least 40%.I take long-term steroids for my autoimmune disease.I have not taken certain medications recently.I am currently experiencing symptoms of graft-versus-host disease.I am able to care for myself and perform daily activities.I am over 18 and have been diagnosed with an aggressive type of B-cell non-Hodgkin lymphoma.I am using birth control as a woman capable of becoming pregnant.My veins are suitable for a blood filtering procedure.
Research Study Groups:
This trial has the following groups:- Group 1: ACALABRUTINIB and LISOCABTAGENE MARALEUCEL
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.