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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib for Mantle Cell Lymphoma

Phase 2

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

Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1

Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months. 1 cycle =28 days

Awards & highlights

Study Summary

This trial will help researchers learn more about how safe and effective ACP-196 is for treating people with a certain type of cancer that has come back or does not respond to other treatments.

Who is the study for?

This trial is for adults over 18 with confirmed Mantle Cell Lymphoma (MCL) who have relapsed or are not responding to treatment. Participants must be relatively fit (ECOG ≤ 2), able to use contraception, and not have severe illnesses that could risk their safety or affect the study drug's absorption.Check my eligibility

What is being tested?

The trial is testing ACP-196 (acalabrutinib) for its effectiveness and safety in patients with MCL that has come back or isn't getting better. It's an open-label, Phase 2 study which means everyone knows they're receiving acalabrutinib and it’s fairly early in the clinical trials process.See study design

What are the potential side effects?

While specific side effects of ACP-196 aren't listed here, similar medications can cause headaches, diarrhea, muscle aches, reduced blood cell counts increasing infection risk, bruising or bleeding easily, irregular heartbeat among others.

Eligibility Criteria

Inclusion Criteria

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

Select...

My Mantle Cell Lymphoma (MCL) has specific genetic markers.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months. 1 cycle =28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months. 1 cycle =28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months. 1 cycle =28 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL.

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

1Treatment groups

Experimental Treatment

Group I: ACP-196 (acalabrutinib) Regimen 1Experimental Treatment1 Intervention

ACP-196 (acalabrutinib) Regimen 1

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor

45 Previous Clinical Trials

5,801 Total Patients Enrolled

Acerta PharmaStudy Director1-888-292-9613

Media Library

ACP-196 (acalabrutinib) (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02213926 — Phase 2

Mantle Cell Lymphoma Research Study Groups: ACP-196 (acalabrutinib) Regimen 1

Mantle Cell Lymphoma Clinical Trial 2023: ACP-196 (acalabrutinib) Highlights & Side Effects. Trial Name: NCT02213926 — Phase 2

ACP-196 (acalabrutinib) (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02213926 — Phase 2

Frequently Asked Questions

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

Is geriatric participation allowed in this experimentation?

"The inclusion criteria for this specific medical trial requires that participants be between 18-130 years of age. There are 310 trials available to individuals under the age of majority and 1639 opportunities for those over 65."

Answered by AI

What ailments can ACP-196 (acalabrutinib) effectively treat?

"ACP-196 (acalabrutinib) can be administered to assist patients with Mantle cell lymphoma, Small Lymphocytic Leukemia and Chronic lymphocytic leukemia."

Answered by AI

How many participants are being administered this treatment?

"Regrettably, this trial has ended its recruitment phase. The research was posted on March 2nd 2015 and recently updated October 12th 2022. If you're seeking other trails to join as a participant, there are 1720 trials related to lymphoma and 75 studies concerning acalabrutinib (ACP-196) that currently have open enrollment opportunities."

Answered by AI

How widely is this medical research being conducted in the city?

"Currently, this experimental study is being conducted in 9 distinct sites. These locations are spread out between Tampa, Niles and Hackensack while the remaining 6 can be found elsewhere. To reduce travel burdens, it's best to select a site close to you if enrolling."

Answered by AI

Am I eligible to enroll in this trial?

"The ideal participants of this medical trial should be between the ages 18 and 130, have been diagnosed with lymphoma, and meet the Eastern Cooperative Oncology Group (ECOG) performance status criteria of ≤ 2. The research team is looking for a total of 124 men and women to take part in this study."

Answered by AI

Is this particular clinical trial an innovative one?

"Since Acerta Pharma BV's initial clinical trial in 2014 involving 306 patients, there have been 24 additional tests of ACP-196 (acalabrutinib) conducted across 507 cities and 47 countries. Currently, 75 studies remain active."

Answered by AI

Could you provide an overview of prior investigations that have included ACP-196 (acalabrutinib)?

"ACP-196 (acalabrutinib) was first tested in 2014 at Research Site. Up until now, 24 trials have been concluded and 75 are presently being conducted with a substantial portion of these studies occurring in Tampa, Florida"

Answered by AI

Is this clinical study currently recruiting participants?

"The recruitment period for this specific clinical trial has concluded. The initial posting was on March 2nd 2015 and the last update occured on October 12th 2022. If seeking other trials, there are 1720 active studies available to lymphoma patients, as well as 75 involving ACP-196 (acalabrutinib)."

Answered by AI

Has ACP-196 (acalabrutinib) obtained regulatory authorization from the Food and Drug Administration?

"Despite ACP-196 (acalabrutinib) not having any clinical data to back its efficacy, it received a rating of 2 for safety due to the Phase 2 trial results available."

Answered by AI