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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Rituximab for B-Cell Lymphoma (ACRUE Trial)

Phase 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 80 years of age at the time of screening, or

≥ 65 to 79 years of age at the time of screening and considered ineligible for chemoimmunotherapy

Must not have

History of or ongoing confirmed Progressive Multifocal Leukoencephalopathy

Any comorbidity or organ system impairment rated with a single Cumulative Illness Rating Scale-Geriatric score (CIRS-G) of 4 or a total CIRS-G score of > 6

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how safe and effective a combination of acalabrutinib and rituximab is in elderly and frail patients with diffuse large B-cell lymphoma who cannot undergo standard chemotherapy

Who is the study for?

This trial is for elderly or frail patients who have not been treated for diffuse large B-cell lymphoma (DLBCL) and are unsuitable for standard treatments. Participants must be over 65 years old, with a performance status of 0-2, meaning they can perform daily activities with varying degrees of assistance. They should also have at least one measurable lesion and adequate organ/marrow function.

What is being tested?

The study tests the combination of Acalabrutinib and Rituximab in untreated elderly/frail patients with DLBCL to assess safety, tolerability, and effectiveness. It's designed for those who cannot undergo standard chemoimmunotherapy due to their age or frailty.

What are the potential side effects?

Potential side effects may include diarrhea, headache, muscle pain, reduced blood cell counts leading to increased infection risk or bleeding problems, irregular heart rhythm, high blood pressure, bruising easily and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 80 years old or older.

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I am between 65 and 79 years old and not eligible for chemoimmunotherapy.

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My diagnosis is diffuse large B-cell lymphoma.

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I have not received any treatment for DLBCL.

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My physical ability hasn't worsened in the last 2 weeks, except for symptoms from my lymphoma.

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I have a tumor that is at least 10 mm large and can be measured by scans.

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My cancer is classified as Stage II, III, or IV.

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My organs and bone marrow work well without needing extra help.

Exclusion Criteria

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

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I have been diagnosed with or currently have Progressive Multifocal Leukoencephalopathy.

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I do not have a severe illness or organ problem scored 4 or a total illness score over 6.

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I haven't had major surgery in the last 30 days and don't plan any during the study.

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

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I have HIV or another serious infection.

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I have a bleeding disorder such as haemophilia or von Willebrand disease.

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I am not currently receiving any cancer treatments.

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I am on blood thinners like warfarin.

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My lymphoma is affecting my brain or spinal cord.

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

Awards & 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 RituximabExperimental Treatment2 Interventions

Patients will receive Dose A of acalabrutinib orally in X dosing schedule beginning on Cycle 1 Day 1 for a maximum of 28 cycles or until 2014 Lugano Classification for Non-Hodgkin's Lymphoma (NHL)-defined disease progression or another discontinuation criterion is met. Patients will also receive an intravenous (IV) infusion of Dose B rituximab on Cycle 1 Day 15 and Dose C of rituximab as an subcutaneous (SC) injection on Day 1 of Cycle 2 through Cycle 8.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2110

Rituximab

1999

Completed Phase 4

~2990