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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Chronic obstructive pulmonary disease

Septic shock

Ischaemic stroke

100%

80%

60%

40%

20%

Study treatment Arm

BSC Alone

Acalabrutinib + BSC

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

~2050

Bendamustine

2015

Completed Phase 3

~2950

Rituximab

1999

Completed Phase 4

~1880

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor

45 Previous Clinical Trials

5,290 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,274 Previous Clinical Trials

288,612,729 Total Patients Enrolled

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02972840 — Phase 3

Mantle Cell Lymphoma Research Study Groups: Acalabrutinib in combination with bendamustine and rituximab, Placebo in combination with bendamustine and rituximab

Mantle Cell Lymphoma Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT02972840 — Phase 3

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02972840 — Phase 3

Frequently Asked Questions

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

What other tests involving Acalabrutinib have been conducted in the past?

"There are 543 ongoing studies investigating the efficacy of Acalabrutinib. Of these, 116 are Phase 3 studies. The largest concentration of these studies is located in Ottignies, Belgium, but there are a total of 18795 clinical trial sites for this medication worldwide."

Answered by AI

Has the FDA cleared Acalabrutinib for public use?

"There is existing clinical evidence to support the efficacy of Acalabrutinib as well as its safety, so it was given a score of 3."

Answered by AI

Is there still room for new participants in this trial?

"The clinical trial is recruiting patients at this time, according to clinicaltrials.gov. This trial was originally posted on 4/5/2017, with the most recent update on 10/20/2022."

Answered by AI

What are the benefits of Acalabrutinib?

"Acalabrutinib is an effective treatment for inflammatory breast cancer (ibc) as well as other issues like b-cell lymphomas, polyangiitis, and drug extravasation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

2017. "A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02972840.

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