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New CLL trial aims to reduce Life-Threatening side effect of cancer drugs

NCT ID NCT06428019

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 3 trial tests different ways to start venetoclax combined with obinutuzumab or acalabrutinib in 170 adults with untreated chronic lymphocytic leukemia (CLL). The goal is to find the safest ramp-up schedule to prevent tumor lysis syndrome, a dangerous side effect. Participants receive one of four dosing plans and are monitored for about 28 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, obinutuzumab, acalabrutinib
What this could lead to
If successful, this could lead to safer, more effective starting regimens for CLL treatment, reducing dangerous side effects like tumor lysis syndrome.
What could go wrong
This is an early-phase study with only 170 participants, so results may not apply to all CLL patients. The combinations may still cause serious side effects or not improve outcomes.

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

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Mar 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: * Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of \> 6 months. * Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation. * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2. * Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol. * Creatinine clearance (CrCl) \>= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion. Exclusion Criteria: \- Active/uncontrolled infection, no Richter's transformation, no active 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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    69 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arizona Oncology - Tucson - Rudasill /ID# 267552

    RECRUITING

    Tucson, Arizona, 85704, United States

  • Atrium Health /ID# 267219

    RECRUITING

    Charlotte, North Carolina, 28204-2963, United States

  • Atrium Health Wake Forest Baptist Medical Center /ID# 273142

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • CHU Amiens-Picardie Site Sud /ID# 266849

    RECRUITING

    Amiens, Somme, 80054, France

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 266969

    RECRUITING

    Madrid, 28027, Spain

  • Calvary Mater Newcastle /ID# 267408

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 266713

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 266445

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • Centre Antoine-Lacassagne /ID# 266894

    RECRUITING

    Nice, Provence-Alpes-Côte d'Azur Region, 06189, France

  • Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 266854

    RECRUITING

    Chambéry, Savoie, 73007, France

  • Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy /ID# 266852

    RECRUITING

    Metz, Moselle, 57085, France

  • Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 266272

    RECRUITING

    Orléans, 45067, France

  • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 266319

    RECRUITING

    St-Priest-en-Jarez, Pays de la Loire Region, 42270, France

  • Centre Hospitalier d Argenteuil Victor Dupouy /ID# 266322

    RECRUITING

    Argenteuil, Île-de-France Region, 95107, France

  • Centre Hospitalier de la Côte Basque /ID# 266847

    RECRUITING

    Bayonne, Pyrenees-Atlantiques, 64109, France

  • China Medical University Hospital /ID# 267018

    RECRUITING

    Taichung, 40447, Taiwan

  • Cleveland Clinic Main Campus /ID# 271292

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinica Universidad de Navarra - Pamplona /ID# 267762

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Clinical Hospital Center - Bežanijska Kosa /ID# 266567

    RECRUITING

    Belgrade, Beograd, 11080, Serbia

  • Clinical Hospital Center Zvezdara /ID# 266560

    RECRUITING

    Belgrade, Beograd, 11000, Serbia

  • Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 267164

    RECRUITING

    Santiago de Compostela, A Coruna, 15706, Spain

  • Comprehensive Hematology Oncology /ID# 267644

    RECRUITING

    St. Petersburg, Florida, 33709, United States

  • Evangelismos Hospital /ID# 266815

    RECRUITING

    Athens, Attica, 10676, Greece

  • General Hospital of Athens Laiko /ID# 266813

    RECRUITING

    Athens, Attica, 11527, Greece

  • Henry Ford Hospital /ID# 270973

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 266270

    RECRUITING

    Créteil, Paris, 94010, France

  • Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 267438

    RECRUITING

    Paris, Paris, 75679, France

  • Hospital MD Anderson Cancer Center Madrid /ID# 267167

    RECRUITING

    Madrid, 28033, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 266967

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Virgen del Rocio /ID# 266968

    RECRUITING

    Seville, 41013, Spain

  • Icahn School of Medicine at Mount Sinai /ID# 266328

    RECRUITING

    New York, New York, 10029, United States

  • Institute for Oncology of Vojvodina /ID# 266556

    RECRUITING

    Kamenitz, Vojvodina, 21208, Serbia

  • Kaohsiung Chang Gung Memorial Hospital /ID# 267046

    RECRUITING

    Kaohsiung City, Kaohsiung, 833, Taiwan

  • Lifespan Cancer Institute - Providence /ID# 266550

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Linkou Chang Gung Memorial Hospital /ID# 267045

    RECRUITING

    Taoyuan City, 333, Taiwan

  • Malcolm Randall V.A. Medical Center /ID# 267825

    RECRUITING

    Gainesville, Florida, 32608, United States

  • Maryland Oncology Hematology - Silver Spring /ID# 267557

    RECRUITING

    Silver Spring, Maryland, 20904, United States

  • Mid Florida Hematology And Oncology Center /ID# 269159

    RECRUITING

    Orange City, Florida, 32763, United States

  • National Taiwan University Hospital /ID# 267017

    RECRUITING

    Taipei, 100, Taiwan

  • Northwest Cancer Center - Dyer Clinic /ID# 268478

    RECRUITING

    Dyer, Indiana, 46311, United States

  • Northwest Medical Specialties Tacoma /ID# 266327

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Nottingham City Hospital /ID# 266991

    RECRUITING

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • Oklahoma Cancer Specialists and Research Institute /ID# 267643

    RECRUITING

    Tulsa, Oklahoma, 74146, United States

  • Olympion General Clinic /ID# 266819

    RECRUITING

    Pátrai, Achaia, 26443, Greece

  • Pan American Center for Oncology Trials /ID# 266243

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • Rocky Mountain Cancer Centers - Aurora /ID# 267549

    RECRUITING

    Aurora, Colorado, 80012, United States

  • Royal Perth Hospital /ID# 266906

    RECRUITING

    Perth, Western Australia, 6000, Australia

  • Saint Lukes Hospital of Kansas City /ID# 267270

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Southern VA Health Care System /ID# 266254

    RECRUITING

    Tucson, Arizona, 85723, United States

  • Springfield Clinic - First /ID# 270145

    RECRUITING

    Springfield, Illinois, 62702, United States

  • St Vincent's Hospital - Melbourne /ID# 270027

    RECRUITING

    Fitzroy, Victoria, 3065, Australia

  • Texas Oncology - Austin Midtown /ID# 268152

    RECRUITING

    Austin, Texas, 78705, United States

  • Townsville University Hospital /ID# 266954

    RECRUITING

    Townsville, Queensland, 4814, Australia

  • UCSF FRESNO/Community Cancer Institute /ID# 270874

    RECRUITING

    Clovis, California, 93611, United States

  • UMass Memorial Medical Center /ID# 270023

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University Clinical Center Kragujevac /ID# 266568

    RECRUITING

    Kragujevac, Sumadijski Okrug, 34000, Serbia

  • University Clinical Center Nis /ID# 266580

    RECRUITING

    Niš, Nisavski Okrug, 18300, Serbia

  • University Clinical Center Serbia /ID# 266579

    RECRUITING

    Belgrade, Beograd, 11000, Serbia

  • University Clinical Center Vojvodina /ID# 266674

    RECRUITING

    Novi Sad, 21000, Serbia

  • University General Hospital Attikon /ID# 266814

    RECRUITING

    Athens, Attica, 12462, Greece

  • University General Hospital of Alexandroupoli /ID# 266816

    RECRUITING

    Alexandroupoli, Evros, 68100, Greece

  • University of Iowa Health Care /ID# 267206

    RECRUITING

    Des Moines, Iowa, 50314-3017, United States

  • University of Texas - Southwestern Medical Center /ID# 266528

    RECRUITING

    Dallas, Texas, 75235, United States

  • Valkyrie Clinical Trials /ID# 268151

    RECRUITING

    Los Angeles, California, 90067, United States

  • Virginia Cancer Specialists - Fairfax /ID# 268155

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Vista Oncology - East Olympia /ID# 267337

    RECRUITING

    Olympia, Washington, 98506, United States

  • West Virginia University School of Medicine /ID# 267645

    RECRUITING

    Morgantown, West Virginia, 26506, United States

  • Willamette Valley Cancer Institute and Research Center /ID# 266326

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Willis-Knighton Medical Center /ID# 270569

    COMPLETED

    Shreveport, Louisiana, 71103, United States

  • Yale University School of Medicine /ID# 266224

    RECRUITING

    New Haven, Connecticut, 06510, United States

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