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New drug shows promise for rare blood cancer

NCT ID NCT02180724

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This phase 2 study tests acalabrutinib, a targeted drug, in 107 people with Waldenström macroglobulinemia, a rare blood cancer. The goal is to see how well the drug shrinks tumors and controls the disease. Participants either had prior treatment or are new to therapy and cannot take standard chemo.

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 successful, this could provide a new treatment option for Waldenström macroglobulinemia that helps control the disease without chemotherapy.
What could go wrong
This is a mid-stage trial with only 107 participants, so results may not apply to everyone. The drug may not work as well in larger groups or could have side effects.

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

107 people

The number who actually took part.

Started

Sep 2014

Expected to finish

Dec 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: 1. Men and women ≥18 years of age. 2. Previously treated cohort only: A confirmed diagnosis of WM, which has relapsed after, or been refractory to ≥1prior therapy for WM and which requires treatment. 3. Previously untreated cohort only: A confirmed diagnosis of previously untreated WM in subjects who require treatment and do not want to receive chemoimmunotherapy or have comorbidities that would preclude chemoimmunotherapy such as: * Symptomatic hyperviscosity with an IgM ≥5,000mg/dL * Disease-related neuropathy 4. Serum concentration of IgM, as measured by SPEP and IFE, that exceeds the upper limits of normal or measurable nodal WM (defined as the presence of ≥1lymph node that measures ≥2.0 cm in the longest diameter and ≥1.0cm in the longest perpendicular diameter). 5. ECOG performance status of ≤2. 6. Women who are sexually active and can bear children must agree to use highly effective forms of contraception during the study and for 2 days after the last dose of acalabrutinib. 7. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty. 8. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations). Exclusion Criteria: 1. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥2 years or which will not limit survival to \<2 years. Note: These cases must be discussed with the medical monitor. 2. 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 acalabrutinib, or put the study outcomes at undue risk. 3. 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 QTc \>480 msec. 4. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. 5. Any immunotherapy within 4 weeks of first dose of study drug. 6. For subjects with recent chemotherapy or experimental therapy, the first dose of study drug must occur after 5 times the half-life of the agent(s). 7. Prior exposure to a BCR inhibitor (e.g., BTK,PI3K, or SYK inhibitors) or BCL-2 inhibitors (e.g., ABT-199). 8. Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids for treatment of WM or other conditions. Note: Subjects may use topical or inhaled corticosteroids or low-dose steroids (≤10 mg of prednisone or equivalent per day) as therapy for comorbid conditions. During study participation, subjects may also receive systemic or enteric corticosteroids as needed for treatment-emergent comorbid conditions. 9. Grade ≥2 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation. 10. Known history of HIV or active infection with HCV or hepatitis B virus (HBV) or any uncontrolled active systemic infection. 11. Major surgery within 4 weeks before first dose of study drug. 12. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura. 13. History of a bleeding diathesis (e.g., hemophilia, von Willebrand disease). 14. History of stroke or intracranial hemorrhage within 6 months before the first dose of acalabrutinib. 15. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 28 days of first dose of study drug. 16. Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). 17. ANC \<0.75 x 109/L or platelet count \<50 x 109/L. For subjects with disease involvement in the bone marrow, ANC \<0.50 x 109/L or platelet count \<30x109/L. 18. Creatinine \>2.5 x institutional ULN; total bilirubin \>2.5 x ULN; or AST or ALT \>3.0 x ULN. 19. Lactating or pregnant. 20. Concurrent participation in another therapeutic clinical trial.

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Conditions

The condition(s) this trial relates to.

Waldenstrom macroglobulinemia

As listed by the trial registrant

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

Waldenström macroglobulinemia (WM)

Contacts and locations

Locations

  • Research Site

    Santa Barbara, California, 93105, United States

  • Research Site

    Aurora, Colorado, 80012, United States

  • Research Site

    Washington D.C., District of Columbia, 20007, United States

  • Research Site

    Minneapolis, Minnesota, 55404, United States

  • Research Site

    New York, New York, 10021, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Austin, Texas, 78705, United States

  • Research Site

    Bedford, Texas, 76022, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Vancouver, Washington, 98684, United States

  • Research Site

    Aurillac, 15002, France

  • Research Site

    Clermond Ferrand, 63003, France

  • Research Site

    Marseille, 13273, France

  • Research Site

    Montpellier, 34295, France

  • Research Site

    Nantes, 44093, France

  • Research Site

    Paris, 75015, France

  • Research Site

    Paris, 75651, France

  • Research Site

    Pierre-Bénite, 69495, France

  • Research Site

    Poitiers, 86021, France

  • Research Site

    Reims, 51092, France

  • Research Site

    Rennes, 35000, France

  • Research Site

    Toulouse, 31059, France

  • Research Site

    Vandœuvre-lès-Nancy, 54500, France

  • Research Site

    Athens, 11528, Greece

  • Research Site

    Bologna, 40138, Italy

  • Research Site

    Milan, 20162, Italy

  • Research Site

    Novara, 28100, Italy

  • Research Site

    Amsterdam, 1105AZ, Netherlands

  • Research Site

    Utrecht, 2508GA, Netherlands

  • Research Site

    Salamanca, 37007, Spain

  • Research Site

    Bournemouth, BH7 7DW, United Kingdom

  • Research Site

    Leeds, LS9 7TF, United Kingdom

  • Research Site

    Leicester, LE1 7RH, United Kingdom

  • Research Site

    London, NW1 2BU, United Kingdom

  • Research Site

    London, SW3 6JJ, United Kingdom

  • Research Site

    Oxford, OX3 7LE, United Kingdom

  • Research Site

    Plymouth, PL6 8DH, United Kingdom

  • Research Site

    Southampton, SO16 6YD, United Kingdom

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