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Can a triple drug combo outsmart High-Risk CLL?

NCT ID NCT05197192

Disease control Sponsor: German CLL Study Group 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This phase 3 trial is investigating whether adding acalabrutinib to a standard combination of obinutuzumab and venetoclax can help people with high-risk chronic lymphocytic leukemia (CLL) live longer without their disease progressing. The study enrolls adults with CLL who have certain genetic risk factors, such as a 17p deletion or TP53 mutation. Participants are randomly assigned to receive either the triple-drug regimen or the standard two-drug regimen, and researchers will compare how long each group remains free of disease progression.

What this could mean

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

Active substance
Acalabrutinib, obinutuzumab, and venetoclax (a triple-drug combination)
What this could lead to
If successful, this could offer a more effective first-line treatment for people with high-risk CLL, potentially delaying disease progression better than the current two-drug approach.
What could go wrong
The trial is still in progress, and adding a third drug may increase side effects without improving outcomes. Results are not yet available, and the benefit may not apply to all patients.

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 202 people

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

Started

Apr 2022

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 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: * Documented CLL/SLL requiring treatment according to iwCLL criteria * Age at least 18 years * At least one of the following risk factors: 17p-deletion, TP53-mutation, complex karyotype (defined as defined as the presence of 3 or more chromosomal aberrations in 2 or more metaphases) or an unmutated IGHV gene status. * Life expectancy ≥ six months * Adequate bone marrow function indicated by a platelet count \>30 x10\^9/l * Creatinine clearance ≥ 30ml/min * Adequate liver function as indicated by a total bilirubin ≤ 2 x, AST/ ALT ≤ 2.5 x the institutional ULN value, unless directly attributable to the patient's CLL or to Gilbert's Syndrome * Negative testing for hepatitis B (HbsAg negative and anti-HBc negative; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every month until 12 months after last treatment cycle),or hepatitis C (negative testing for hepatitis C RNA within 6 wee * ks prior to registration for study screening (i.e. PCR only required when serology was positive)) * ECOG (Eastern Cooperative Oncology Group Performance Status) status 0-2 Exclusion Criteria: * Any prior CLL-specific therapies (except corticosteroid treatment administered due to necessary immediate intervention; within the last 10 days before start of study treatment, only dose equivalents up to 20 mg prednisolone are permitted) * Absence of high risk disease (17p-deletion, TP53-mutation complex karyotype * An individual organ/system impairment score of 4 as assessed by the CIRS definition (e.g. advanced cardiac disease (NYHA class 3 or 4) limiting the ability to receive the study treatment or any other life-threatening illness, medical condition or organ system dysfunction that, in the investigator´s opinion, could compromise the patients safety or interfere with the absorption or metabolism of the study drugs (e.g. inability to swallow tablets or impaired resorption in the gastrointestinal tract) * Transformation of CLL (Richter transformation) * Malignancies other than CLL currently requiring systemic therapies * Uncontrolled or active infection of HIV/PML or any other active infection * Anticoagulant therapy with warfarin or phenoprocoumon * Pregnant women and nursing mothers

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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

    30 sites. 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

  • Brüderkrankenhaus St. Josef Paderborn

    RECRUITING

    Paderborn, 33098, Germany

  • Caritas-Klinik St. Theresia

    RECRUITING

    Saarbrücken, 66113, Germany

  • DRK Kliniken Berlin Köpenick

    RECRUITING

    Berlin, 12559, Germany

  • Ev. Diakoniekrankenhaus

    RECRUITING

    Bremen, 28239, Germany

  • Helios Klinikum Bad Saarow

    RECRUITING

    Bad Saarow, 15526, Germany

  • KH Kliniken Maria Hilf

    RECRUITING

    Mönchengladbach, 41063, Germany

  • Katholisches Krankenhaus Hagen - St. Josefs Hospital

    RECRUITING

    Hagen, 58097, Germany

  • Kliniken Ostalb, Stauferklinikum Schwäbisch Gmünd

    RECRUITING

    Mutlangen, 73557, Germany

  • Klinikum Hochsauerland - St. Walburga Krankenhaus

    RECRUITING

    Meschede, 59872, Germany

  • Klinikum Idar-Oberstein SHG

    RECRUITING

    Idar-Oberstein, 55743, Germany

  • Klinikum Landshut

    RECRUITING

    Landshut, 84034, Germany

  • Klinikum Lippe-Lemgo

    RECRUITING

    Lemgo, 32657, Germany

  • Klinikum Oldenburg

    RECRUITING

    Oldenburg, 26133, Germany

  • Klinikum Rechts der Isar - Technische Universitaet Muenchen

    RECRUITING

    Munich, 81675, Germany

  • Klinikum Sindelfingen-Böbingen

    RECRUITING

    Sindelfingen, 71065, Germany

  • Krankenhaus Muenchen-Schwabing

    RECRUITING

    Munich, 80804, Germany

  • Marien Hospital Düsseldorf

    RECRUITING

    Düsseldorf, 40479, Germany

  • Marienhospital Stuttgart

    RECRUITING

    Stuttgart, 70199, Germany

  • St Vincenz Krankenhaus

    RECRUITING

    Limburg, 65549, Germany

  • St. Antonius-Hospital

    RECRUITING

    Eschweiler, 52249, Germany

  • St. Johannes Hospital

    RECRUITING

    Dortmund, 44137, Germany

  • Staedtisches Klinikum Karlsruhe

    RECRUITING

    Karlsruhe, 76133, Germany

  • Universitaetsklinik Tuebingen

    RECRUITING

    Tübingen, 72076, Germany

  • Universitaetskliniken des Saarlandes

    RECRUITING

    Homburg, 66424, Germany

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • Universitaetsklinikum Magdeburg

    RECRUITING

    Magdeburg, 39120, Germany

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    RECRUITING

    Kiel, 24116, Germany

  • Universitätsklinik Köln

    RECRUITING

    Cologne, 50937, Germany

  • Universitätsklinik Rostock

    RECRUITING

    Rostock, 18057, Germany

  • Universitätsklinik Ulm

    RECRUITING

    Ulm, 89081, Germany

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