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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

Must not have

Received platelet transfusion within the past 1 week

Estimated glomerular filtration rate < 30 mL/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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I can perform daily activities with little to no assistance.

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I am between 18 and 70 years old.

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My lymphoma is high grade with specific genetic changes.

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My kidney function is good, with a creatinine clearance rate of at least 60 mL/min.

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My large B-cell lymphoma has spread to my brain.

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My disease improved or disappeared before my transplant.

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I am receiving a stem cell transplant for large B-cell lymphoma.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I received a platelet transfusion in the last week.

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My kidney function is severely reduced.

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I have not received a live virus vaccine in the last 28 days.

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I have a bleeding disorder such as hemophilia.

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I currently have an active fungal infection.

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I have or had progressive multifocal leukoencephalopathy.

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I have not had major surgery in the last 30 days or have fully recovered if I did.

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I have severe stomach or bowel problems that affect my ability to absorb medication.

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I have been diagnosed with HIV.

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My stem cell transplant will use cord blood as the donor source.

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My heart condition severely limits my daily activities.

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I am on blood thinners like warfarin.

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I am currently taking posaconazole or similar strong medications that cannot be replaced.

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I have severe graft-versus-host disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Permanent discontinuation of acalabrutinib

Secondary study objectives

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 study objectives

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

Headache

Septic shock

Ischaemic stroke

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

BSC Alone

Acalabrutinib + BSC

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2110

0 / 24Eligibility criteria met