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Phase 2 study of the combination of ibrutinib plus venetoclax in subjects with treatment-naïve chronic lymphocytic Leukemia/Small lymphocytic lymphoma

NCT ID NCT02910583

NEW Sponsor: Pharmacyclics LLC. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 10, 2026

Summary

This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL.

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

323 people

The number who actually took part.

Started

Sep 2016

Finished

Mar 2024

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 to 70 years

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 CLL/SLL that meets 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) diagnostic criteria (Hallek et al), with active disease meeting at least 1 IWCLL criteria for requiring treatment. * Measurable nodal disease by computed tomography (CT) * Adequate hepatic, and renal function * Adequate hematologic function * absolute neutrophil count \>750/µL * platelet count \>30,000 /μL * hemoglobin \>8.0 g/dL Exclusion Criteria: * Any prior therapy used for treatment of CLL/SLL * Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk for tumor lysis syndrome (TLS)

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia leukemia

As listed by the trial registrant

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

Chronic lymphocytic leukemia Leukemia Small lymphocytic lymphoma

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 1142-0581

    Milan, 20162, Italy

  • Austin Health /ID# 1142-0170

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera di Padova /ID# 1142-1175

    Padova, 35128, Italy

  • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 1142-0582

    Novara, 28100, Italy

  • Azienda Ospedaliero-Universitaria di Modena /ID# 1142-0524

    Modena, 41124, Italy

  • Azienda USL di Piacenza - Ospedale Guglielmo da Saliceto /ID# 1142-1182

    Piacenza, 29121, Italy

  • Charlotte-Mecklenberg Hospital, Carolinas Healthcare System, Levine Cancer Inst /ID# 1142-0733

    Charlotte, North Carolina, 28203, United States

  • Christchurch Hospital /ID# 1142-0589

    Christchurch, Canterbury, 8011, New Zealand

  • City of Hope /ID# 1142-0047

    Duarte, California, 91010, United States

  • Cleveland Clinic Foundation /ID# 1142-0739

    Cleveland, Ohio, 44195, United States

  • Complejo Hospitalario de Navarra /ID# 1142-1197

    Pamplona, Navarre, 31008, Spain

  • Duplicate_Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie /ID# 1142-0590

    Lublin, Lublin Voivodeship, 20-081, Poland

  • Flinders Medical Centre /ID# 1142-0163

    Bedford Park, South Australia, 5042, Australia

  • Frankston Hospital /ID# 1142-0715

    Frankston, Victoria, 3199, Australia

  • Hospital Clinic de Barcelona /ID# 1142-0533

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Salamanca /ID# 1142-0790

    Salamanca, 37007, Spain

  • Hospital Duran i Reynals /ID# 1142-0604

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital Santa Creu i Sant Pau /ID# 1142-0535

    Barcelona, 08041, Spain

  • Hospital Universitario 12 de Octubre /ID# 1142-0864

    Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 1142-0536

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Ramon y Cajal /ID# 1142-0874

    Madrid, 28034, Spain

  • Hospital Universitario Virgen de las Nieves /ID# 1142-1196

    Granada, 18014, Spain

  • MD Anderson Cancer Center /ID# 1142-0032

    Houston, Texas, 77030, United States

  • Malopolskie Centrum Medyczne /ID# 1142-0364

    Krakow, Lesser Poland Voivodeship, 30-510, Poland

  • Medical Univ. of Lodz and Copernicus Memorial Hospital /ID# 1142-0531

    Lodz, 93-510, Poland

  • Middlemore Hospital /ID# 1142-0662

    Otahuhu, Auckland, 2025, New Zealand

  • Monash Medical Centre /ID# 1142-0556

    Clayton, Victoria, 3168, Australia

  • Moores Cancer Center at UC San Diego /ID# 1142-0241

    La Jolla, California, 92093, United States

  • New York Presbyterian Hospital/Weill Cornell Med College /ID# 1142-0200

    New York, New York, 10021, United States

  • North Shore Hospital /ID# 1142-0663

    Auckland, 0622, New Zealand

  • Northwell Health/Long Island Jewish Hospital /ID# 1142-0350

    New Hyde Park, New York, 11042, United States

  • Norton Cancer Center /ID# 1142-0071

    Louisville, Kentucky, 40202, United States

  • Ospedale Policlinico San Martino /ID# 1142-0903

    Genova, 16132, Italy

  • Ospedale San Raffaele IRCCS /ID# 1142-0523

    Milan, Lombardy, 20132, Italy

  • Palmerston North Hospital /ID# 1142-0585

    Palmerston North, Manawatu-Wanganui, 4414, New Zealand

  • Peter MacCallum Cancer Centre-East Melbourne /ID# 1142-0633

    East Melbourne, Victoria, 3002, Australia

  • Rutgers Cancer Institute of New Jersey /ID# 1142-1193

    New Brunswick, New Jersey, 08901, United States

  • Samodzielny Publiczny Szpital Klinczny Nr-1- Akademickie Cenrum Klinic /ID# 1142-0529

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • St George Hospital /ID# 1142-0654

    Kogarah, New South Wales, 2217, Australia

  • St Vincent's Hospital Melbourne /ID# 1142-0501

    Fitzroy, Victoria, 3065, Australia

  • Swedish Cancer Institute /ID# 1142-0114

    Seattle, Washington, 98104, United States

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. /ID# 1142-0592

    Brzozów, Podkarpackie Voivodeship, 36-200, Poland

  • Tennessee Oncology - Chattanooga /ID# 1142-0123

    Chattanooga, Tennessee, 37404-1108, United States

  • UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 1142-0008

    Orange, California, 92868-3201, United States

  • University of Pennsylvania /ID# 1142-0069

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester Cancer Center /ID# 1142-0127

    Rochester, New York, 14642-0001, United States

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