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Acalabrutinib Maintenance for Large B-cell Lymphoma

Phase 1 & 2
Recruiting
Led By Caspian Oliai, MD
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Disease status of PR or CR after post-CAR T-cell therapy positron emission tomography (PET)-computed tomography (CT) at 1-3 months
Eastern Cooperative Oncology Group (ECOG) 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help keep cancer from coming back after cellular therapy.

Who is the study for?
This trial is for adults aged 18-70 with large B-cell lymphoma who've had a positive response to CAR T-cell therapy or stem cell transplant. They must have good kidney function, not be pregnant, and agree to use contraception. Exclusions include heart problems, recent transfusions, active infections, certain drug treatments, and inability to swallow pills.Check my eligibility
What is being tested?
The trial tests acalabrutinib as a maintenance treatment after cellular therapy in patients at high risk of relapse. Acalabrutinib is designed to block cancer growth by inhibiting specific proteins within the cancer cells.See study design
What are the potential side effects?
Acalabrutinib may cause side effects such as headaches, diarrhea, muscle pain, reduced blood cell counts leading to increased infection risk or bleeding issues. It can also potentially cause irregular heartbeat or hypertension.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My PET-CT scan shows partial or complete response 1-3 months after CAR T-cell therapy.
Select...
I can perform daily activities with little to no assistance.
Select...
I am between 18 and 70 years old.
Select...
My lymphoma is high grade with specific genetic changes.
Select...
My kidney function is good, with a creatinine clearance rate of at least 60 mL/min.
Select...
My large B-cell lymphoma has spread to my brain.
Select...
My disease improved or disappeared before my transplant.
Select...
I am receiving a stem cell transplant for large B-cell lymphoma.
Select...
My slow-growing lymphoma has changed into a more aggressive large B-cell type.
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I am receiving a milder form of treatment preparation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Permanent discontinuation of acalabrutinib
Secondary outcome measures
Incidence of dose reductions, interruptions, or discontinuations of acalabrutinib based on the protocol criteria
Incidence of graft versus host disease (GvHD) >= stage 2
Incidence of hematologic adverse events
+5 more
Other outcome measures
Acalabrutinib metabolite
CAR T-cell persistence
Immunophenotyping of peripheral blood mononuclear cells
+1 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199
2%
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: Group III (acalabrutinib)Experimental Treatment1 Intervention
Beginning anytime between days 28-104, patients receive acalabrutinib PO BID until day 365 in the absence of disease progression or unacceptable toxicity.
Group II: Group II (acalabrutinib)Experimental Treatment1 Intervention
Beginning day 60, patients receive acalabrutinib PO QD and then PO BID from day 74 if there are no dose reductions until day 365 in the absence of disease progression or unacceptable toxicity.
Group III: Group I (acalabrutinib)Experimental Treatment1 Intervention
Beginning day 90, patients receive acalabrutinib PO QD and then PO BID once no longer on prophylactic antifungal (CYP34A inhibitors) until day 365 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2050

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,008 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,265 Previous Clinical Trials
288,605,258 Total Patients Enrolled
Caspian Oliai, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
3 Previous Clinical Trials
15 Total Patients Enrolled

Media Library

Acalabrutinib Clinical Trial Eligibility Overview. Trial Name: NCT05256641 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Group I (acalabrutinib), Group II (acalabrutinib), Group III (acalabrutinib)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT05256641 — Phase 1 & 2
Acalabrutinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT05256641 — Phase 1 & 2

Frequently Asked Questions

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

Is this research endeavor accepting volunteers at this time?

"Reportedly, this medical trial is not presently enrolling candidates. This study was posted on January 30th 2023 and last updated October 19th 2022. However, there are a plethora of other clinical trials actively seeking participants at the moment with 1776 active projects in total."

Answered by AI

Who qualifies to take part in this clinical examination?

"Qualified applicants must meet two criteria: they should have dlbcl and be aged between 18-70. As of now, the research program is searching for 24 participants."

Answered by AI

Does the trial have any age restrictions, particularly for those in their fourth decade of life?

"This clinical trial requires that participants are of adult age and younger than 70 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma
2023. "Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05256641.
~6 spots leftby Oct 2024
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