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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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~time from first response to disease progression or death up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first response to disease progression or death up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response rate (CRR)
Secondary outcome measures
Duration of Response
ER visit rates
Event free survival
+10 more

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
Jeremy Abramson, MDLead Sponsor
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,613,333 Total Patients Enrolled

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05583149 — Phase 2
Follicular Lymphoma Research Study Groups: ACALABRUTINIB and LISOCABTAGENE MARALEUCEL
Follicular Lymphoma Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT05583149 — Phase 2
Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05583149 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment spots available for this trial at the moment?

"At present, the study is not accepting any more enrolments. The original post date was October 1st 2022 and the last update occurred on October 13th of that same year. Nevertheless, there are an abundance of other clinical trials actively recruiting patients right now which totals 1843 active studies."

Answered by AI

To what extent is ACALABRUTINIB and LISOCABTAGENE MARALEUCEL hazardous to the health of individuals?

"Data supporting the safety of ACALABRUTINIB and LISOCABTAGENE MARALEUCEL is limited, so it was classified with a score of 2. This reflects that while some preliminary evidence exists on its safety, no information has been collected regarding efficacy as this is only Phase Two trial."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~11 spots leftby Mar 2025