CLL/SLLPhase 1/2AETHERNCT05791409
Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL
A Phase 1/2 study testing Epcoritamab and Venetoclax in people with CLL/SLL, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 29 sites in 5 countries.
Trial summary
In this study, efficacy and safety of 2 regimens that combine the CD3-CD20 T cell engager epcoritamab with venetoclax will be tested in relapsed/refractory CLL and SLL patients. The trial starts with phase I part to establish the recommended dose level (RDL) of epcoritamab in the combination with venetoclax for the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL/SLL
- What is being tested?
- Epcoritamab and Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 29 sitesin 5 countries
- Study dates
- 15 Apr 2024to Dec 2032
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 18Show fewer
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
29 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Mark-David Levin contact
29 sites in 5 countries
Netherlands12 sites, 11 recruiting
- Recruiting
NL-Den Bosch-JBZ
's-Hertogenbosch
- Withdrawn
NL-Alkmaar-NWZ
Alkmaar
- Recruiting
NL-Amersfoort-MEANDERMC
Amersfoort
- Recruiting
NL-Amsterdam-AMC
Amsterdam
- Recruiting
NL-Dordrecht-ASZ
Dordrecht
- Recruiting
NL-Ede-ZGV
Ede
- Recruiting
NL-Eindhoven-CATHARINA
Eindhoven
- Recruiting
NL-Groningen-UMCG
Groningen
- Recruiting
NL-Leeuwarden-MCL
Leeuwarden
- Recruiting
NL-Den Haag-HAGA
The Hague
- Recruiting
NL-Tilburg-ETZ
Tilburg
- Recruiting
NL-Utrecht-UMCUTRECHT
Utrecht
Germany9 sites, 7 recruiting
- Withdrawn
DE-Berlin-HELIOSBERLINBUCH
Berlin
- Recruiting
DE-Köln-UKKOELN
Cologne
- Recruiting
DE-Freiburg-UNIKLINIKFREIBURG
Freiburg im Breisgau
- Withdrawn
DE-Greifswald-UNIGREIFSWALD
Greifswald
- Recruiting
DE-Halle-UMH
Halle
- Recruiting
DE-Kiel-UKSH
Kiel
- Recruiting
DE-Munster-GEMEINSCHAFTSPRAXIS
Münster
- Recruiting
DE-Stuttgart-RBK
Stuttgart
- Recruiting
DE-Ulm-UNIKLINKULM
Ulm
Australia3 sites, 3 recruiting
- Recruiting
AU-Melbourne-ALFRED
Melbourne
- Recruiting
AU-Melbourne-MONASH
Melbourne
- Recruiting
AU-Melbourne-SVHM
Melbourne
Denmark3 sites, 2 recruiting
- Withdrawn
DK-Aalborg-ALBOGUH
Aalborg
- Recruiting
DK-Copenhagen-RIGSHOSPITALET
Copenhagen
- Recruiting
DK-Odense-OUH
Odense
Belgium2 sites, 2 recruiting
- Recruiting
BE-Antwerpen-ZNASTUIVENBERG
Antwerp
- Recruiting
BE-Roeselare-AZDELTA
Roeselare
About this study
Official title: A Prospective Randomized Phase I/II Trial of Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
In this study, efficacy and safety of 2 regimens that combine the CD3-CD20 T cell engager epcoritamab with venetoclax will be tested in relapsed/refractory CLL and SLL patients. The trial starts with phase I part to establish the recommended dose level (RDL) of epcoritamab in the combination with venetoclax for the phase II trial.
- Conditions
- CLL/SLL
- Being tested
- Epcoritamab, Venetoclax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpcoritamabDrug
Number of cycles of epcoritamab is either 6 (cycle 1-6) or 12 (cycle 1-12). Patients will be treated until they have received the total number of assigned treatment cycles or until progression, or severe toxicity, whichever comes first.
VenetoclaxDrug
All patients will receive venetoclax cycle 1-26 (a 5 week ramp-up of venetoclax will precede the first cycle). Patients will be treated until they have received the total number of assigned treatment cycles or until progression, or severe toxicity, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 6 cycles epcoritamab + 26 cycles venetoclax Receives: Drug: Epcoritamab; Drug: Venetoclax |
| Arm B | Experimental | 12 cycles epcoritamab + 26 cycles venetoclax Receives: Drug: Epcoritamab; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Recommended phase II dose (RP2D) for the combination of venetoclax and epcoritamab based on dose limiting toxicity (DLT)
endpoint for phase I and both arms
Measured: 6-12 months
• Undetectable minimal residual disease <10-4 (uMRD) in BM in absence of progression according to IWCLL criteria at 12 weeks after cycle 26
endpoint for phase II and both arms
Measured: 29 months
Secondary outcomes (14)
• Minimal residual disease (MRD) status in PB at cycle 4, 6, 9, 12, 15, 18, 21, 24 and 12 weeks after cycle 26; following treatment: every 3 months for the first year, then every 6 months until relapse or until 6 years after registration
both arms
Measured: 6 years
• Progression free survival (PFS), defined as time from registration to the first occurrence of disease progression or death from any cause, whichever occurs first.
both arms
Measured: 6 years
Overall survival (OS), defined as the time from registration to death from any cause.
both arms
Measured: 6 years
Best overall response rate (ORR) defined as the proportion of patients with a complete response (CR), complete response with incomplete marrow recovery (CRi), or partial response (PR) according to IWCLL 2018 criteria.
both arms
Measured: 6 years
• Event free survival (EFS), defined as time from randomization to date start of next CLL treatment, progression or death, whichever comes first.
both arms
Measured: 6 years
• Time to next CLL treatment (TTNT), defined as time from randomization to next new line of treatment.
both arms
Measured: 6 years
• Treatment free survival (TFS), defined as time from date of last protocol treatment to date start of next (new) line of treatment, or death from any cause, whichever comes first.
both arms
Measured: 6 years
Duration of response (DOR), defined as time from first response (i.e., ≥PR and CR) to PD or death from any cause.
both arms
Measured: 6 years
• Depth (level) of minimal residual disease (MRD) measured in BM after cycle 9 and 12 weeks after cycle 26.
both arms
Measured: 29 months
• Depth (level) of minimal residual disease measured in PB at cycle 4, 6, 9, 12, 15, 18, 21, 24, 12 weeks after cycle 26 and thereafter every 3 months for the first year, then every 6 months until relapse or until 6 years after registration
both arms
Measured: 6 years
Safety parameters: Type, frequency, and severity of- adverse events (AEs) and- adverse events of special interest (AESI) and their relationship to study treatment (determined according to CTCAE v5.0).
both arms
Measured: 6 years
Health-related quality of life (QoL) by EORTC QLQ-C30 questionnaires.
both arms
Measured: 6 years
Health-related quality of life (QoL) by QLQ-CLL17 questionnaires.
both arms
Measured: 6 years
Health-related quality of life (QoL) by PRO-CTCAE questionnaires.
both arms
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start15 Apr 2024
- Primary completionMar 2029 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLL/SLLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic CLL Study Group, The Australasian Leukaemia & Lymphoma Group (ALLG), German CLL Study Group (GCLLSG)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791409
- Sponsor's protocol ID
- HO165 CLL
- Acronym
- AETHER
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Phase I/II Trial of Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT05791409
- Acronym / sponsor ID
- AETHER / HO165 CLL
- Conditions
- CLL/SLL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Stichting Hemato-Oncologie voor Volwassenen NederlandUniversity, hospital or other
- Collaborators
- Nordic CLL Study Group, The Australasian Leukaemia & Lymphoma Group (ALLG), German CLL Study Group (GCLLSG)
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, efficacy and safety of 2 regimens that combine the CD3-CD20 T cell engager epcoritamab with venetoclax will be tested in relapsed/refractory CLL and SLL patients. The trial starts with phase I part to establish the recommended dose level (RDL) of epcoritamab in the combination with venetoclax for the phase II trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Epcoritamab, Drug: Venetoclax6 cycles epcoritamab + 26 cycles venetoclax |
| Arm B | Experimental | Drug: Epcoritamab, Drug: Venetoclax12 cycles epcoritamab + 26 cycles venetoclax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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;
Key exclusion criteria (30 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpcoritamabNumber of cycles of epcoritamab is either 6 (cycle 1-6) or 12 (cycle 1-12). Patients will be treated until they have received the total number of assigned treatment cycles or until progression, or severe toxicity, whichever comes first. | Drug | Arm A, Arm B |
| VenetoclaxAll patients will receive venetoclax cycle 1-26 (a 5 week ramp-up of venetoclax will precede the first cycle). Patients will be treated until they have received the total number of assigned treatment cycles or until progression, or severe toxicity, whichever comes first. | Drug | Arm A, Arm B |
Primary outcome
• Recommended phase II dose (RP2D) for the combination of venetoclax and epcoritamab based on dose limiting toxicity (DLT)
Time frame: 6-12 months
endpoint for phase I and both arms
• Undetectable minimal residual disease <10-4 (uMRD) in BM in absence of progression according to IWCLL criteria at 12 weeks after cycle 26
Time frame: 29 months
endpoint for phase II and both arms
14 secondary outcomes
• Minimal residual disease (MRD) status in PB at cycle 4, 6, 9, 12, 15, 18, 21, 24 and 12 weeks after cycle 26; following treatment: every 3 months for the first year, then every 6 months until relapse or until 6 years after registration
Time frame: 6 years
• Progression free survival (PFS), defined as time from registration to the first occurrence of disease progression or death from any cause, whichever occurs first.
Time frame: 6 years
Overall survival (OS), defined as the time from registration to death from any cause.
Time frame: 6 years
Best overall response rate (ORR) defined as the proportion of patients with a complete response (CR), complete response with incomplete marrow recovery (CRi), or partial response (PR) according to IWCLL 2018 criteria.
Time frame: 6 years
• Event free survival (EFS), defined as time from randomization to date start of next CLL treatment, progression or death, whichever comes first.
Time frame: 6 years
• Time to next CLL treatment (TTNT), defined as time from randomization to next new line of treatment.
Time frame: 6 years
• Treatment free survival (TFS), defined as time from date of last protocol treatment to date start of next (new) line of treatment, or death from any cause, whichever comes first.
Time frame: 6 years
Duration of response (DOR), defined as time from first response (i.e., ≥PR and CR) to PD or death from any cause.
Time frame: 6 years
• Depth (level) of minimal residual disease (MRD) measured in BM after cycle 9 and 12 weeks after cycle 26.
Time frame: 29 months
• Depth (level) of minimal residual disease measured in PB at cycle 4, 6, 9, 12, 15, 18, 21, 24, 12 weeks after cycle 26 and thereafter every 3 months for the first year, then every 6 months until relapse or until 6 years after registration
Time frame: 6 years
Safety parameters: Type, frequency, and severity of- adverse events (AEs) and- adverse events of special interest (AESI) and their relationship to study treatment (determined according to CTCAE v5.0).
Time frame: 6 years
Health-related quality of life (QoL) by EORTC QLQ-C30 questionnaires.
Time frame: 6 years
Health-related quality of life (QoL) by QLQ-CLL17 questionnaires.
Time frame: 6 years
Health-related quality of life (QoL) by PRO-CTCAE questionnaires.
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark-David Levin contact
29 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Epcoritamab and Venetoclax in people with CLL/SLL, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 29 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Netherlands, Germany, Australia, Denmark, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arnon Kater (+31 6-11491753, a.p.kater@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Recommended phase II dose (RP2D) for the combination of venetoclax and epcoritamab based on dose limiting toxicity (DLT) (time frame: 6-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.