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Two-Drug combo aims to push relapsed leukemia into deep remission

NCT ID NCT05791409

Disease control Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 05, 2026 · Last updated Oct 06, 2026 · Updated 1 time

Summary

Researchers are testing a combination of two drugs, venetoclax and epcoritamab, in adults whose chronic lymphocytic leukemia or small lymphocytic lymphoma has come back or stopped responding to treatment. All participants receive venetoclax for 26 cycles, while the number of epcoritamab cycles is either 6 or 12. The trial first finds a safe dose of epcoritamab to use with venetoclax, then checks whether the combination clears cancer cells to undetectable levels in the bone marrow.

What this could mean

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

Active substance
a combination of venetoclax and epcoritamab
What this could lead to
If the combination works, it could offer people with relapsed CLL or SLL a way to reach deep, hard-to-detect remission and delay the disease's return.
What could go wrong
This is an early-phase trial with about 112 participants, so it cannot prove the combination works better than standard care. The drugs can cause serious side effects, and the results may not hold up in larger studies.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 112 people

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

Started

Apr 2024

Expected to finish

Dec 2032

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 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: * Documented relapsed or refractory CLL or SLL (SLL in phase II part only) following at least one systemic 1st-line treatment * Requiring treatment according to IWCLL criteria (appendix A); * Age at least 18 years; * ECOG/WHO performance status 0-2; * In case of prior venetoclax treatment, enrollment can only occur at least 24 months after end of treatment and patients must not have progressed during venetoclax treatment; * Adequate BM function defined as: * Hemoglobin \>5.6 mmol/l or Hb \> 9 g/dL, unless low Hb is directly attributable to CLL infiltration of the BM, proven by BM biopsy; * Absolute neutrophil count (ANC) \>1.0 x 109/L (1,000/μL), unless low ANC is directly attributable to CLL infiltration of the BM, proven by BM biopsy; * Platelet count \>30 x 109/L (30,000/μL), unless low platelets is directly attributable to CLL infiltration in the BM; * Estimated Glomerular Filtration Rate (eGFR) (MDRD) or estimated creatinine clearance (CrCl) ≥ 50ml/min (Cockcroft-Gault appendix F); * Adequate liver function as indicated: * Serum aspartate transaminase (ASAT) and alanine transaminase (ALAT) ≤ 3.0 x upper limit of normal (ULN); * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or controlled autoimmune hemolytic anemia); * Prothrombin time (PT)/International normal ratio (INR) \<1.5x ULN and activated partial thromboplastin time (aPTT) \<1.5 x ULN; unless receiving anticoagulation; * Negative serological testing for hepatitis B virus (HBV) (Hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (anti-HBc) negative) and hepatitis C virus (hepatitis C antibody). Patients who are positive for anti-HBc or hepatitis C antibody may be included if they have a negative PCR within 6 weeks before enrollment. Those who are PCR positive will be excluded; Please note: For patients positive for anti-HBc, HBV-DNA PCR has to be repeated every month until 12 months after last dose of study treatment. * Patient is able and willing to adhere to the study visit schedule and other protocol requirements; * Patient is capable of giving informed consent; * Written informed consent. Exclusion Criteria: * Active CLL/SLL directed therapy within the last 14 days; * Prior treatment with a CD3 × CD20 bispecific antibody or CAR T-cell therapy * Transformation of CLL (Richter's transformation); * Prior allogeneic stem cell transplantation and/or solid organ transplantation; * Patient with a history of confirmed progressive multifocal leukoencephalopathy (PML); * Malignancies other than CLL currently requiring systemic therapy or not treated in curative intention or showing signs of progression after curative treatment; * Known allergy to xanthine oxidase inhibitors and/or rasburicase; * History of drug-specific hypersensitivity or anaphylaxis to any study drug (including active product or excipient components); * Active bleeding or uncontrolled severe bleeding diathesis (e.g., hemophilia or severe von Willebrand disease); * Active fungal, bacterial, and/or viral infection CTCAEgrade \> 1; Please note: active controlled as well as chronic/recurrent infections are at risk of reactivation/infection during treatment; * Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled: infection, auto-immune hemolysis, immune thrombocytopenia, diabetes, hypertension, hyperthyroidism or hypothyroidism etc.); * Patient known to be HIV-positive; * Patient requiring treatment with a strong cytochrome P450 (CYP) 3A inhibitor/inducer (see appendix J) or anticoagulant therapy with warfarin or phenoprocoumon or other vitamin K antagonists; * CTCAE grade III-IV cardiovascular disease including but not limited to: * Unstable or uncontrolled disease/condition related to or affecting cardiac function, eg, unstable angina, congestive heart failure grade III or IV as classified by the New York Heart Association (see appendix E), uncontrolled clinically significant cardiac arrhythmia (CTCAE grade II or higher), or clinically significant electrocardiogram (ECG) abnormalities. * Myocardial infarction, intracranial bleed, or stroke within the past 6 months. * Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \>480 msec. NOTE: this criterion does not apply to subjects with a left bundle branch block. * Stroke or intracranial hemorrhage within 6 months prior to registration. * Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D); * Severe neurological or psychiatric disease (CTCAE grade III-IV, see appendix D); * Neuropathy \> CTCAE grade II * Patient who has difficulty with or are unable to swallow oral medication, or have significant gastrointestinal disease that would limit absorption of oral medication; * Vaccination with live vaccines within 28 days prior to registration; * Use of any other experimental drug or therapy within 28 days of registration; * Major surgery within 28 days prior to registration; * Pregnant women and nursing mothers; * Fertile men or women of childbearing potential unless: (1) surgically sterile or ≥ 2 years after the onset of menopause; (2) willing to use a highly effective contraceptive method such as oral contraceptives, intrauterine device, sexual abstinence or combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods) during study treatment and for 12 months after last dose of epcoritamab and 30 days after last dose of venetoclax; * Previous participation in the HOVON 139 CLL or HOVON 140 CLL trial and eligible for and willing to participate in the HOVON 159 CLL trial; * Current participation in other clinical trial with medicinal products; * Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma

As listed by the trial registrant

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

CLL / SLL

How to take part

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

  1. The places running it

    25 sites in 5 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

  • AU-Melbourne-ALFRED

    RECRUITING

    Melbourne, Australia

  • AU-Melbourne-MONASH

    RECRUITING

    Melbourne, Australia

  • AU-Melbourne-SVHM

    RECRUITING

    Melbourne, Australia

  • BE-Antwerpen-ZNASTUIVENBERG

    RECRUITING

    Antwerp, Belgium

  • BE-Roeselare-AZDELTA

    RECRUITING

    Roeselare, Belgium

  • DE-Berlin-HELIOSBERLINBUCH

    WITHDRAWN

    Berlin, Germany

  • DE-Freiburg-UNIKLINIKFREIBURG

    RECRUITING

    Freiburg im Breisgau, Germany

  • DE-Greifswald-UNIGREIFSWALD

    WITHDRAWN

    Greifswald, Germany

  • DE-Halle-UMH

    RECRUITING

    Halle, Germany

  • DE-Kiel-UKSH

    RECRUITING

    Kiel, Germany

  • DE-Köln-UKKOELN

    RECRUITING

    Cologne, Germany

  • DE-Munster-GEMEINSCHAFTSPRAXIS

    RECRUITING

    Münster, Germany

  • DE-Stuttgart-RBK

    RECRUITING

    Stuttgart, Germany

  • DE-Ulm-UNIKLINKULM

    RECRUITING

    Ulm, Germany

  • DK-Aalborg-ALBOGUH

    WITHDRAWN

    Aalborg, Denmark

  • DK-Copenhagen-RIGSHOSPITALET

    RECRUITING

    Copenhagen, Denmark

  • DK-Odense-OUH

    RECRUITING

    Odense, Denmark

  • NL-Alkmaar-NWZ

    WITHDRAWN

    Alkmaar, Netherlands

  • NL-Amersfoort-MEANDERMC

    RECRUITING

    Amersfoort, Netherlands

  • NL-Amsterdam-AMC

    RECRUITING

    Amsterdam, Netherlands

  • NL-Den Bosch-JBZ

    RECRUITING

    's-Hertogenbosch, Netherlands

  • NL-Den Haag-HAGA

    RECRUITING

    The Hague, Netherlands

  • NL-Dordrecht-ASZ

    RECRUITING

    Dordrecht, Netherlands

  • NL-Ede-ZGV

    RECRUITING

    Ede, Netherlands

  • NL-Eindhoven-CATHARINA

    RECRUITING

    Eindhoven, Netherlands

  • NL-Groningen-UMCG

    RECRUITING

    Groningen, Netherlands

  • NL-Leeuwarden-MCL

    RECRUITING

    Leeuwarden, Netherlands

  • NL-Tilburg-ETZ

    RECRUITING

    Tilburg, Netherlands

  • NL-Utrecht-UMCUTRECHT

    RECRUITING

    Utrecht, Netherlands

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