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New hope for lymphoma patients who Can't tolerate standard drugs

NCT ID NCT04116437

Disease control Sponsor: BeiGene 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a drug called zanubrutinib in 96 people with certain types of B-cell lymphoma (like chronic lymphocytic leukemia or mantle cell lymphoma) who had bad side effects from similar drugs like ibrutinib or acalabrutinib. The main goal was to see if zanubrutinib causes fewer or less severe side effects. Researchers also checked if the drug helped control the cancer. This is not a cure, but a way to manage the disease with ongoing treatment.

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

96 people

The number who actually took part.

Started

Oct 2019

Finished

Jan 2026

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.

Key Inclusion Criteria: 1. Participants must meet protocol defined disease criteria requiring treatment for their respective disease prior to initiation of ibrutinib or acalabrutinib 2. Ibrutinib and acalabrutinib intolerance is defined as an unacceptable toxicity where, in the opinion of the investigator, treatment should be discontinued in spite of optimal supportive care as a result of one of the following: 1. For ibrutinib and acalabrutinib intolerance events: * 1 or more ≥ Grade 2 nonhematologic toxicities for \>7 days (with or without treatment) * 1 or more ≥ Grade 3 nonhematologic toxicity of any duration * 1 or more Grade 3 neutropenia with infection or fever of any duration; or * Grade 4 heme toxicity which persists to the point that the investigator chose to stop therapy due to toxicity NOT progression. 2. For acalabrutinib intolerance events only; * 1 or more ≥ Grade 1 nonhematologic toxicities of any duration with \> 3 recurrent episodes; or * 1 or more ≥ Grade 1 nonhematologic toxicities for \> 7 days (with or without treatment); or * Inability to use acid-reducing agents or anticoagulants (eg, proton pump inhibitors, warfarin) due to concurrent acalabrutinib use 3. Ibrutinib and/or acalabrutinib-related ≥ Grade 2 toxicities must have resolved to ≤ Grade 1 or baseline prior to initiating treatment with zanubrutinib. Grade 1 acalabrutinib-related toxicities must have resolved to Grade 0 or baseline prior to initiating treatment with zanubrutinib. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 5. Absolute neutrophil count (ANC) ≥ 1000/mm\^3 with or without growth factor support and platelet count ≥ 50,000/mm\^3 (may be post-transfusion), on or prior to C1D1 of zanubrutinib Key Exclusion Criteria: 1. Clinically significant cardiovascular disease including the following: 1. Myocardial infarction within 6 months before the Screening 2. Unstable angina within 3 months before the Screening 3. New York Heart Association class III or IV congestive heart failure 4. History of sustained ventricular tachycardia, ventricular fibrillation, and/or Torsades de Pointes 5. QT interval corrected by Fridericia's formula \> 480 milliseconds 6. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place 2. History of central nervous system (CNS) hemorrhage 3. Documented progressive disease (PD) during ibrutinib and/or acalabrutinib treatment. 4. Have received any anticancer therapy (other than immunotherapy) for CLL/SLL, WM, MCL, and MZL \< 7 days before any Screening assessments are performed or any immunotherapy treatment, taken alone or as part of a chemoimmunotherapy regimen, \< 4 weeks before any Screening assessments are performed 5. Requires ongoing need for corticosteroid treatment \> 10 mg daily of prednisone or equivalent corticosteroid. Note: Systemic corticosteroids must be fully tapered off/discontinued ≥ 5 days before the first dose of study drug is administered. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma Lymphoma, B-Cell, Marginal Zone mantle cell lymphoma marginal zone lymphoma Waldenstrom macroglobulinemia

As listed by the trial registrant

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

Chronic lymphocytic leukemia/small lymphocytic lymphoma Mantle cell lymphoma Marginal zone lymphoma Waldenstrom macroglobulinemia

Contacts and locations

Locations

  • Abington Hematology Oncology Associates

    Horsham, Pennsylvania, 19044-2331, United States

  • Baylor Research Institute

    Dallas, Texas, 75246-2079, United States

  • Christiana Care

    Newark, Delaware, 19713-2055, United States

  • Clinical Research Alliance, Inc

    Westbury, New York, 11590-5119, United States

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169-3321, United States

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-4433, United States

  • Healthcare Research Network Iii, Llc

    Flossmoor, Illinois, 60422-2067, United States

  • Medical Oncology Associates

    Spokane, Washington, 99208-1129, United States

  • Minnesota Oncology Burnsville Clinic

    Burnsville, Minnesota, 55337-6749, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960-6136, United States

  • Oncology Associates of Oregon Willamette Valley Cancer Center

    Eugene, Oregon, 97401, United States

  • Rocky Mountain Cancer Centers (Williams) Usor

    Aurora, Colorado, 80012-5405, United States

  • Scri Florida Cancer Specialists North

    St. Petersburg, Florida, 33705-1449, United States

  • Scri Florida Cancer Specialists South

    Fort Myers, Florida, 33901-8108, United States

  • Ssm Health Cancer Care Dean Medical Center

    Madison, Wisconsin, 53717-1959, United States

  • St Century Oncology

    Jacksonville, Florida, 32204-1128, United States

  • St Lukes University Health Network

    Fountain Hill, Pennsylvania, 18015-1153, United States

  • Summit Medical Group

    Florham Park, New Jersey, 07932-1049, United States

  • Tennessee Oncology, Pllc Nashville

    Nashville, Tennessee, 37203, United States

  • Texas Oncology Amarillo

    Amarillo, Texas, 79106-1781, United States

  • Texas Oncology McAllen South Second Street

    McAllen, Texas, 78503, United States

  • Texas Oncology Tyler Longview

    Austin, Texas, 78705-1163, United States

  • Us Oncology Virginia Cancer Specialists, Pc

    Fairfax, Virginia, 22031-4629, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502-2800, United States

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