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New hope for tough lymphoma: targeted drug shows promise in Mid-Stage trial

NCT ID NCT02213926

Disease control Sponsor: Acerta Pharma BV Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study tests a drug called ACP-196 (acalabrutinib) in 124 adults with mantle cell lymphoma that has returned or not responded to prior therapy. The main goal is to see how many patients have their tumors shrink or disappear. This is an open-label, phase 2 trial, meaning everyone gets the drug and researchers are checking for safety and effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

124 people

The number who actually took part.

Started

Mar 2015

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Men and women ≥ 18 years of age. * 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. * Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children. Exclusion criteria: * A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196 (acalabrutinib), or put the study outcomes at undue risk * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) \> 480 msec. * Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. * Breast feeding or pregnant

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Conditions

The condition(s) this trial relates to.

mantle cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mantle cell lymphoma (MCL)

Contacts and locations

Locations

  • Research Site

    Tampa, Florida, 33612, United States

  • Research Site

    Chicago, Illinois, 60612, United States

  • Research Site

    Niles, Illinois, 60714, United States

  • Research Site

    Peoria, Illinois, 61615, United States

  • Research Site

    Boston, Massachusetts, 2215, United States

  • Research Site

    Hackensack, New Jersey, 07601, United States

  • Research Site

    New York, New York, 10021, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Seattle, Washington, 98109, United States

  • Research Site

    Monash, Australia

  • Research Site

    Sydney, 2139, Australia

  • Research Site

    Wodonga, 3690, Australia

  • Research Site

    Bruges, 8000, Belgium

  • Research Site

    Brussels, 1000, Belgium

  • Research Site

    Brussels, 1200, Belgium

  • Research Site

    Liège, 4000, Belgium

  • Research Site

    Yvoir, 5530, Belgium

  • Research Site

    Prague, 100 34, CZ, Czechia

  • Research Site

    Angers, 49033, France

  • Research Site

    Caen, 14033, France

  • Research Site

    Clermond Ferrand, 63003, France

  • Research Site

    Créteil, 94010, France

  • Research Site

    Dijon, 21000, France

  • Research Site

    Grenoble, 38043, France

  • Research Site

    La Roche - Sure-Yon, 85925, France

  • Research Site

    Lille, 59000, France

  • Research Site

    Montpellier, 34295, France

  • Research Site

    Nantes, 44093, France

  • Research Site

    Paris, 75015, France

  • Research Site

    Paris, 75651, France

  • Research Site

    Pessac, 33604, France

  • Research Site

    Pierre-Bénite, 69310, France

  • Research Site

    Rennes, 35033, France

  • Research Site

    Rouen, 76038, France

  • Research Site

    Saint-Priest-en-Jarez, 42270, France

  • Research Site

    Strasbourg, 67098, France

  • Research Site

    Toulouse, 31100, France

  • Research Site

    Tours, 37000, France

  • Research Site

    Vandœuvre-lès-Nancy, 54500, France

  • Research Site

    Bologna, 40138, Italy

  • Research Site

    Meldola, 47014, Italy

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Novara, 28100, Italy

  • Research Site

    Amsterdam, 1105 AZ, Netherlands

  • Research Site

    Maastricht, 6202 AZ, Netherlands

  • Research Site

    Rotterdam, 3062 PA, Netherlands

  • Research Site

    Krakow, 30-727, Poland

  • Research Site

    Lodz, 93-510, Poland

  • Research Site

    Olsztyn, 10-228, Poland

  • Research Site

    Badalona, 8916, Spain

  • Research Site

    Pamplona, 31008, Spain

  • Research Site

    Cardiff, CF14 4XW, United Kingdom

  • Research Site

    Leeds, LS9 7TF, United Kingdom

  • Research Site

    Leicester, LE1 7RH, United Kingdom

  • Research Site

    Nottingham, NG5 1PB, United Kingdom

  • Research Site

    Oxford, 0X3 7LE, United Kingdom

  • Research Site

    Plymouth, PL6 8DH, United Kingdom

  • Research Site

    Southampton, SO16 6YD, United Kingdom

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