Actively Recruiting
Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL
Led by Stichting Hemato-Oncologie voor Volwassenen Nederland · Updated on 2024-04-12
112
Participants Needed
24
Research Sites
446 weeks
Total Duration
On this page
Sponsors
S
Stichting Hemato-Oncologie voor Volwassenen Nederland
Lead Sponsor
N
Nordic CLL Study Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented relapsed or refractory CLL or SLL (SLL only in phase II) after at least one prior systemic treatment
- Requires treatment according to IWCLL criteria
- Age 18 years or older
- ECOG/WHO performance status of 0 to 2
- Prior venetoclax treatment allowed if at least 24 months since last dose and no progression during treatment
- Adequate bone marrow function with hemoglobin >5.6 mmol/l or >9 g/dL unless due to CLL infiltration
- Absolute neutrophil count >1.0 x 10^9/L unless due to CLL infiltration
- Platelet count >30 x 10^9/L unless due to CLL infiltration
- Kidney function (eGFR or creatinine clearance) ≥ 50 ml/min
- Adequate liver function with ASAT and ALAT ≤ 3.0 x upper limit of normal
- Bilirubin ≤ 1.5 x upper limit of normal unless caused by Gilbert's syndrome or controlled autoimmune hemolytic anemia
- Prothrombin time and activated partial thromboplastin time <1.5 x upper limit of normal unless on anticoagulation
- Negative hepatitis B surface antigen and core antibody, and negative hepatitis C antibody or PCR if positive
- Able and willing to adhere to study schedule and protocol
- Capable of giving informed consent
- Written informed consent provided
You will not qualify if you...
- Active CLL or SLL treatment within the last 14 days
- Prior treatment with CD3 × CD20 bispecific antibodies or CAR T-cell therapy
- Transformation of CLL (Richter's transformation)
- Prior allogeneic stem cell or solid organ transplantation
- History of progressive multifocal leukoencephalopathy (PML)
- Other malignancies requiring systemic therapy or not cured
- Allergy to xanthine oxidase inhibitors or rasburicase
- History of drug hypersensitivity or anaphylaxis to study drugs
- Active or uncontrolled severe bleeding disorders
- Active fungal, bacterial, or viral infection grade > 1
- Severe or uncontrolled medical conditions like infection, autoimmune hemolysis, thrombocytopenia, diabetes, hypertension, thyroid disorders
- Known HIV infection
- Treatment with strong CYP3A inhibitors/inducers or certain anticoagulants
- Severe cardiovascular disease or recent myocardial infarction, stroke, or intracranial bleed
- Severe lung dysfunction
- Severe neurological or psychiatric disease
- Neuropathy grade > 2
- Difficulty swallowing oral medication or gastrointestinal disease affecting absorption
- Live vaccination within 28 days before registration
- Use of experimental drugs within 28 days before registration
- Major surgery within 28 days before registration
- Pregnant or nursing women
- Fertile men or women of childbearing potential not using effective contraception
- Previous participation in related HOVON trials
- Current participation in other clinical trials with medicinal products
- Psychological, familial, social, or geographic conditions affecting compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
BE-Antwerpen-ZNASTUIVENBERG
Antwerp, Belgium
Not Yet Recruiting
2
BE-Roeselare-AZDELTA
Roeselare, Belgium
Not Yet Recruiting
3
DK-Aalborg-ALBOGUH
Aalborg, Denmark
Not Yet Recruiting
4
DK-Copenhagen-RIGSHOSPITALET
Copenhagen, Denmark
Actively Recruiting
5
DK-Odense-OUH
Odense, Denmark
Not Yet Recruiting
6
DE-Berlin-HELIOSBERLINBUCH
Berlin, Germany
Not Yet Recruiting
7
DE-Köln-UKKOELN
Cologne, Germany
Not Yet Recruiting
8
DE-Freiburg-UNIKLINIKFREIBURG
Freiburg im Breisgau, Germany
Not Yet Recruiting
9
DE-Greifswald-UNIGREIFSWALD
Greifswald, Germany
Not Yet Recruiting
10
DE-Munster-GEMEINSCHAFTSPRAXIS
Münster, Germany
Not Yet Recruiting
11
DE-Stuttgart-RBK
Stuttgart, Germany
Not Yet Recruiting
12
DE-Ulm-UNIKLINKULM
Ulm, Germany
Not Yet Recruiting
13
NL-Den Bosch-JBZ
's-Hertogenbosch, Netherlands
Not Yet Recruiting
14
NL-Alkmaar-NWZ
Alkmaar, Netherlands
Not Yet Recruiting
15
NL-Amersfoort-MEANDERMC
Amersfoort, Netherlands
Not Yet Recruiting
16
NL-Amsterdam-AMC
Amsterdam, Netherlands
Not Yet Recruiting
17
NL-Dordrecht-ASZ
Dordrecht, Netherlands
Not Yet Recruiting
18
NL-Ede-ZGV
Ede, Netherlands
Not Yet Recruiting
19
NL-Eindhoven-CATHARINA
Eindhoven, Netherlands
Not Yet Recruiting
20
NL-Groningen-UMCG
Groningen, Netherlands
Not Yet Recruiting
21
NL-Leeuwarden-MCL
Leeuwarden, Netherlands
Not Yet Recruiting
22
NL-Den Haag-HAGA
The Hague, Netherlands
Not Yet Recruiting
23
NL-Tilburg-ETZ
Tilburg, Netherlands
Not Yet Recruiting
24
NL-Utrecht-UMCUTRECHT
Utrecht, Netherlands
Not Yet Recruiting
Research Team
A
Arnon Kater
CONTACT
M
Mark-David Levin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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