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Can adding venetoclax let CLL patients pause therapy?

NCT ID NCT06524375

Disease control Sponsor: Genentech, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 2 trial is testing whether adding venetoclax to standard BTK inhibitor therapy can help people with chronic lymphocytic leukemia (CLL) achieve very deep remission. The goal is to see if patients can then safely stop all treatment for a period. The study involves 118 adults who have been on a BTK inhibitor for at least 6 months.

What this could mean

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

Active substance
Venetoclax (a targeted drug) added to a BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib)
What this could lead to
If successful, this could allow some CLL patients to stop treatment temporarily while keeping the disease under control.
What could go wrong
This is a small, early-phase trial without a comparison group. Adding venetoclax may increase side effects, and not all patients will achieve deep remission.

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

118 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Jan 2030

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. Diagnosed with CLL and currently receiving a stable dose of cBTKi (i.e., ibrutinib, acalabrutinib, or zanubrutinib) for at least 6 months for 1L treatment with a response of at least a PR per iwCLL criteria 2. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (\</=) 2 3. Adequate renal and liver function Exclusion Criteria: 1. Prior B-cell lymphoma (Bcl-2) inhibitor therapy 2. Anti-cluster of differentiation 20 (CD20) therapy within the month prior to screening 3. Progressive or stable disease on cBTKi 4. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia) 5. History of cardiomyopathy 6. Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose) 7. Clinically significant cardiovascular disease 8. Active bleeding or history of bleeding diathesis 9. Pregnant women and nursing mothers 10. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia

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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

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland, 20817-1915, United States

  • Asante Rogue Regional Medical Center

    Medford, Oregon, 97504-8332, United States

  • Astera Cancer Care East Brunswick

    East Brunswick, New Jersey, 08816-4096, United States

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256-6932, United States

  • Dana-Farber Cancer Institute - Hematologic Oncology Treatment Center

    Boston, Massachusetts, 02215-5418, United States

  • Fort Wayne Medical Oncology and Hematology, Inc

    Fort Wayne, Indiana, 46804, United States

  • Highlands Oncology Group

    Springdale, Arkansas, 72762, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Mission Blood and Cancer - MercyOne Cancer Center

    Des Moines, Iowa, 50314-3030, United States

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130-2042, United States

  • Nebraska Cancer Specialists St Francis - Grand Island

    Grand Island, Nebraska, 68803, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Oncology Hematology Care Inc - Cincinnati - USOR

    Cincinnati, Ohio, 45236-2725, United States

  • Rocky Mountain Cancer Centers (Aurora) - USOR

    Aurora, Colorado, 80012-5405, United States

  • San Juan Oncology Associates, PC

    Farmington, New Mexico, 87401, United States

  • Tennessee Oncology - Midtown

    Nashville, Tennessee, 37203, United States

  • Tennessee Oncology, PLLC - Chattanooga

    Chattanooga, Tennessee, 37404, United States

  • Texas Oncology- Northeast Texas

    Tyler, Texas, 75702, United States

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401-6043, United States

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