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New CLL drug acalabrutinib takes on ibrutinib in Head-to-Head trial

NCT ID NCT02477696

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether acalabrutinib is as effective as ibrutinib for people with high-risk chronic lymphocytic leukemia (CLL) who have already tried other treatments. About 533 participants will receive either acalabrutinib or ibrutinib pills. The main goal is to see how long people live without their cancer getting worse. The study also tracks serious infections and other side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acalabrutinib
What this could lead to
If acalabrutinib works as well as ibrutinib but with fewer side effects, it could become a preferred treatment option for people with high-risk CLL.
What could go wrong
This is a non-inferiority trial, so acalabrutinib may not prove better than ibrutinib. Both drugs have risks like infections and bleeding. Results may not apply to all CLL patients.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

533 people

The number who actually took part.

Started

Jul 2015

Expected to finish

Jan 2028

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. * ECOG performance status of 0 to 2. * Diagnosis of CLL. * Must have ≥ 1 of the following high-risk prognostic factors: * Presence of 17p del by central laboratory. * Presence of 11q del by central laboratory. * Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment * Must have received ≥ 1 prior therapies for CLL. * Meet the following laboratory parameters: * Absolute neutrophil count (ANC) ≥ 750 cells/μL or ≥ 500 cells/μL in participants with documented bone marrow involvement, and independent of growth factor support 7 days before assessment. * Platelet count ≥ 30,000 cells/μL without transfusion support 7 days before assessment. Participants with transfusion-dependent thrombocytopenia are excluded. * Serum aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3.0 x upper limit of normal (ULN). * Total bilirubin ≤ 1.5 x ULN. * Estimated creatinine clearance ≥ 30 mL/min. Exclusion Criteria: * Known CNS lymphoma or leukemia. * Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome. * Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura. * Prior exposure to ibrutinib or to a B-cell receptor (BCR) inhibitor or a B-cell lymphoma-2 (BCL-2) inhibitor. * Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug. * Prior radio- or toxin-conjugated antibody therapy. * Prior allogeneic stem cell or autologous transplant. * Major surgery within 4 weeks before first dose of study drug. * Prior malignancy, except for adequately treated lentigo maligna melanoma, non-melanomatous skin cancer, in situ cervical carcinoma or other malignancy treated with no evidence of active disease \> 3 years before Screening and at low risk for recurrence. * Significant cardiovascular disease within 6 months of screening. * Known history of infection with human immunodeficiency virus (HIV). * History of stroke or intracranial hemorrhage within 6 months before randomization. * History of bleeding diathesis. * Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug. * Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor/inducer.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

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

Chronic lymphocytic leukemia

Contacts and locations

Locations

  • Research Site

    Phoenix, Arizona, 85054, United States

  • Research Site

    Anaheim, California, 92801, United States

  • Research Site

    Berkeley, California, 94704, United States

  • Research Site

    Duarte, California, 91010, United States

  • Research Site

    La Jolla, California, 92093, United States

  • Research Site

    Los Angeles, California, 90095, United States

  • Research Site

    Palo Alto, California, 94304, United States

  • Research Site

    Santa Rosa, California, 95403, United States

  • Research Site

    Jacksonville, Florida, 32224, United States

  • Research Site

    Tampa, Florida, 33612, United States

  • Research Site

    Athens, Georgia, 30607, United States

  • Research Site

    Harvey, Illinois, 60426, United States

  • Research Site

    Peoria, Illinois, 61615, United States

  • Research Site

    Wichita, Kansas, 67214, United States

  • Research Site

    Minneapolis, Minnesota, 55426, United States

  • Research Site

    Rochester, Minnesota, 55905, United States

  • Research Site

    Billings, Montana, 59102, United States

  • Research Site

    Hackensack, New Jersey, ?07601, United States

  • Research Site

    Lake Success, New York, 11042, United States

  • Research Site

    New Hyde Park, New York, 11042, United States

  • Research Site

    New York, New York, 10021, United States

  • Research Site

    New York, New York, 10029, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    Durham, North Carolina, 27710, United States

  • Research Site

    Columbus, Ohio, 43210, United States

  • Research Site

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Round Rock, Texas, 78665, United States

  • Research Site

    Charlottesville, Virginia, 22908, United States

  • Research Site

    Tacoma, Washington, 98405, United States

  • Research Site

    Northwest WA, Wisconsin, 20007, United States

  • Research Site

    Darlinghurst, 2010, Australia

  • Research Site

    Frankston, 3199, Australia

  • Research Site

    Melbourne, 3000, Australia

  • Research Site

    St Leonards, 2065, Australia

  • Research Site

    Waratah NSW, 2298, Australia

  • Research Site

    Wollongong, 2500, Australia

  • Research Site

    Bruges, 8000, Belgium

  • Research Site

    Brussels, 1200, Belgium

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Yvoir, 5530, Belgium

  • Research Site

    Aalborg, 9100, Denmark

  • Research Site

    Indgang 27B, DK-4000, Denmark

  • Research Site

    Bobigny, 93000, France

  • Research Site

    Créteil, 94010, France

  • Research Site

    Pierre-Bénite, 69310, France

  • Research Site

    Rennes, 35000, France

  • Research Site

    Rouen, 76038, France

  • Research Site

    Toulouse, 31059, France

  • Research Site

    München, 81241, Germany

  • Research Site

    Ulm, 89081, Germany

  • Research Site

    Budapest, 1083, Hungary

  • Research Site

    Budapest, 1122, Hungary

  • Research Site

    Debrecen, 4032, Hungary

  • Research Site

    Kaposvár, 7400, Hungary

  • Research Site

    Haifa, 31000, Israel

  • Research Site

    Haifa, 31096, Israel

  • Research Site

    Haifa, 34362, Israel

  • Research Site

    Jerusalem, 9103102, Israel

  • Research Site

    Nahariya, 22100, Israel

  • Research Site

    Petah Tikvah, 49102, Israel

  • Research Site

    Tel Litwinsky, 52621, Israel

  • Research Site

    Tiberias, 15208, Israel

  • Research Site

    Bologna, 40138, Italy

  • Research Site

    Cagliari, 9121, Italy

  • Research Site

    Cona, 44124, Italy

  • Research Site

    Florence, 50134, Italy

  • Research Site

    Meldola, 47014, Italy

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Milan, 20162, Italy

  • Research Site

    Modena, 41100, Italy

  • Research Site

    Ravenna, 48121, Italy

  • Research Site

    Rome, 168, Italy

  • Research Site

    Almere Stad, 1315 RA, Netherlands

  • Research Site

    Amsterdam, 1105 AZ, Netherlands

  • Research Site

    Blaricum, 1261, Netherlands

  • Research Site

    Breda, 4818 CK, Netherlands

  • Research Site

    Delft, 2600 GA, Netherlands

  • Research Site

    Dordrecht, 3317, Netherlands

  • Research Site

    Geleen, 6162 BG, Netherlands

  • Research Site

    Groningen, 9700, Netherlands

  • Research Site

    Haarlem, 2035 RC, Netherlands

  • Research Site

    Leiden, 2333, Netherlands

  • Research Site

    Rotterdam, 3062 PA, Netherlands

  • Research Site

    Rotterdam, 3083 AN, Netherlands

  • Research Site

    Utrecht, 3584, Netherlands

  • Research Site

    Zutphens, 7207 AE, Netherlands

  • Research Site

    Addington, 8011, New Zealand

  • Research Site

    Auckland, ?0620, New Zealand

  • Research Site

    Tauranga, 3112, New Zealand

  • Research Site

    Bydgoszcz, 85-168, Poland

  • Research Site

    Gdansk, 80-129, Poland

  • Research Site

    Gdynia, 81-519, Poland

  • Research Site

    Krakow, 30-727, Poland

  • Research Site

    Lodz, 93-510, Poland

  • Research Site

    Olsztyn, 10-228, Poland

  • Research Site

    Opole, 46-020, Poland

  • Research Site

    Słupsk, 76-200, Poland

  • Research Site

    Wroclaw, 50-001, Poland

  • Research Site

    Barcelona, 8907, Spain

  • Research Site

    Barcelona, ?08041, Spain

  • Research Site

    Madrid, 28006, Spain

  • Research Site

    Madrid, 28009, Spain

  • Research Site

    Madrid, 28031, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Majadahonda, 28222, Spain

  • Research Site

    Murcia, 30008, Spain

  • Research Site

    Santander, 39008, Spain

  • Research Site

    Ankara, 6230, Turkey (Türkiye)

  • Research Site

    Ankara, 6560, Turkey (Türkiye)

  • Research Site

    Instabul, 34365, Turkey (Türkiye)

  • Research Site

    Izmir, 35040, Turkey (Türkiye)

  • Research Site

    Izmir, 35340, Turkey (Türkiye)

  • Research Site

    Kayseri, 38030, Turkey (Türkiye)

  • Research Site

    Birmingham, B9 5SS, United Kingdom

  • Research Site

    Bournemouth, BH7 7DW, United Kingdom

  • Research Site

    Cambridge, CB2 0QQ, United Kingdom

  • Research Site

    Cardiff, CF14 4XW, United Kingdom

  • Research Site

    Greater London, E1 2AD, United Kingdom

  • Research Site

    Hull, HU32JZ, United Kingdom

  • Research Site

    Leeds, LS9 7TF, United Kingdom

  • Research Site

    Leicester, LE1 7RH, United Kingdom

  • Research Site

    Liverpool, L7 8XP, United Kingdom

  • Research Site

    London, SE5 9RS, United Kingdom

  • Research Site

    Manchester, M20 4BX, United Kingdom

  • Research Site

    Nottingham, NG5 1PB, United Kingdom

  • Research Site

    Plymouth, PL6 8DH, United Kingdom

  • Research Site

    Southampton, SO16 6YD, United Kingdom

  • Research Site

    Surrey, SM2 5PT, United Kingdom

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