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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + BR for Mantle Cell Lymphoma

Phase 3

Waitlist Available

Research Sponsored by Acerta Pharma BV

Eligibility Criteria Checklist

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

Must have

Men and women, ≥ 65 years of age

MCL requiring treatment and for which no prior systemic anticancer therapies have been received

Must not have

Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass

Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti infective treatment within 2 weeks before first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new cancer drug to see if it's more effective than the current standard of care for mantle cell lymphoma.

Who is the study for?

This trial is for men and women aged 65 or older with untreated mantle cell lymphoma (MCL) confirmed by specific genetic markers. Participants must be relatively active and healthy, as indicated by an ECOG performance status of ≤2, and agree to use effective contraception. Those with significant gastrointestinal issues, uncontrolled infections, recent heart problems, or a long QT interval on ECG are excluded.

What is being tested?

The study tests the effectiveness of acalabrutinib combined with bendamustine and rituximab (BR) against a placebo plus BR in patients who have not previously been treated for MCL. The goal is to see if adding acalabrutinib improves treatment outcomes compared to the standard BR therapy alone.

What are the potential side effects?

Potential side effects include digestive disturbances due to bendamustine; infusion reactions from rituximab; headaches, diarrhea, muscle pain from acalabrutinib; and general risks like infection increase due to immune system impact from all drugs involved.

Eligibility Criteria

Inclusion Criteria

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

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I am 65 years old or older.

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My Mantle Cell Lymphoma needs treatment and I haven't received any systemic anticancer therapies before.

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I can take care of myself but might not be able to do heavy physical work.

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My cancer (MCL) has specific genetic features (t(11;14) translocation or cyclin D1 overexpression).

Exclusion Criteria

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

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I do not have any significant issues with my digestive system that could affect medication absorption.

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I do not have an ongoing serious infection that is not getting better with treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 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

Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2

Secondary study objectives

IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2

IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2

IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2

+3 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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Acalabrutinib in combination with bendamustine and rituximabExperimental Treatment3 Interventions

Acalabrutinib administered twice per day (BID) orally (PO) plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.

Group II: Placebo in combination with bendamustine and rituximabPlacebo Group3 Interventions

Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2080

Bendamustine

2015