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New treatment option for CLL/SLL
Official title Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL
ClinicalTrials.gov ID: NCT05791409
What this study is testing
What is Epcoritamab?
Epcoritamab is an investigational medicine, being studied as a potential treatment for cll/sll.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
See the full eligibility criteria
Who can 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:
- 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...
- 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.
What rules you out
- 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)...
- 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 people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Antwerp, Belgium
- Roeselare, Belgium
- Aalborg, Denmark
- Copenhagen, Denmark
- Odense, Denmark
- Berlin, Germany
- Cologne, Germany
- Freiburg im Breisgau, Germany
- Greifswald, Germany
- Münster, Germany
- Stuttgart, Germany
- Ulm, Germany
- 's-Hertogenbosch, Netherlands
- Alkmaar, Netherlands
- Amersfoort, Netherlands
- Amsterdam, Netherlands
- Dordrecht, Netherlands
- Ede, Netherlands
- Eindhoven, Netherlands
- Groningen, Netherlands
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Antwerp, Belgium; Roeselare, Belgium; Aalborg, Denmark; Copenhagen, Denmark; Odense, Denmark; Berlin, Germany and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.