Actively Recruiting
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
Led by Stichting Hemato-Oncologie voor Volwassenen Nederland · Updated on 2024-04-12
112
Participants Needed
24
Research Sites
191 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
Researchers are evaluating the safety and effectiveness of two treatment plans combining the CD3-CD20 T cell engager epcoritamab with venetoclax in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study begins with a Phase I portion to find the right dose of epcoritamab to use with venetoclax for the Phase II part of the trial. This trial is designed to improve treatment options for patients who have already received prior therapies. Participants will be randomly assigned to receive either 6 cycles or 12 cycles of epcoritamab alongside 26 cycles of venetoclax. Venetoclax treatment starts with a 5-week ramp-up before beginning the full cycles. Treatment continues until patients complete their assigned cycles, experience disease progression, or develop severe side effects. The study treatments are given as drug regimens over several months according to the assigned group. Throughout the study, participants will have regular monitoring, including tests to detect minimal residual disease in bone marrow and blood at various cycles and follow-up points up to six years. Safety will be closely observed by tracking adverse events and quality of life using questionnaires. Researchers will also assess overall survival, progression-free survival, and response rates to understand how the treatments affect disease control and patient wellbeing over time.
CONDITIONS
Brief 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 after at least one systemic first-line treatment
- Requires treatment according to IWCLL criteria
- Age 18 years or older
- ECOG/WHO performance status 0 to 2
- If previously treated with venetoclax, at least 24 months since end of treatment without progression
- Adequate bone marrow function: hemoglobin >9 g/dL, neutrophils >1.0 x 10^9/L, platelets >30 x 10^9/L unless low counts are due to CLL
- Kidney function with eGFR or creatinine clearance ≥50 ml/min
- Adequate liver function: ASAT and ALAT ≤3 times upper limit, bilirubin ≤1.5 times upper limit (exceptions apply)
- Prothrombin time/INR <1.5x upper limit and aPTT <1.5x upper limit unless on anticoagulation
- Negative hepatitis B and C tests or controlled infection with negative PCR
- Ability and willingness to follow study schedule
- Capable of giving informed consent
- Signed informed consent form
You will not qualify if you...
- Active CLL/SLL treatment within 14 days prior to enrollment
- Prior treatment with CD3 x CD20 bispecific antibody 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 active malignancies needing treatment or progressing after curative therapy
- Known allergy to xanthine oxidase inhibitors or rasburicase
- Drug hypersensitivity or anaphylaxis to study drugs or components
- Active bleeding or severe bleeding disorders
- Active infections above CTCAE grade 1
- Severe uncontrolled medical conditions (e.g., infections, autoimmune diseases, diabetes, hypertension, thyroid disorders)
- HIV positive status
- Treatment requiring strong CYP3A inhibitors or certain anticoagulants
- Severe cardiovascular disease (e.g., unstable angina, heart failure NYHA III-IV, recent heart attack or stroke)
- Severe lung, neurological, or psychiatric diseases (CTCAE grade III-IV)
- Neuropathy greater than CTCAE grade II
- Difficulty swallowing or gastrointestinal disease limiting oral medication absorption
- Live vaccinations within 28 days prior to enrollment
- Use of other experimental drugs within 28 days
- Major surgery within 28 days
- Pregnant or nursing women
- Fertile men or women not using highly effective contraception during and after treatment
- Previous participation in related trials or current participation in other medicinal product trials
- Conditions impeding compliance with study protocol and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants undergo a 5 week ramp-up phase of venetoclax before starting treatment cycles.
Visits according to ramp-up schedule
Duration - Up to 26 cycles (approximately 26 months)
Participants receive up to 26 cycles of venetoclax combined with either 6 or 12 cycles of epcoritamab, depending on randomization. Treatment continues until completion of assigned cycles, disease progression, or severe toxicity.
Visits scheduled in accordance with treatment cycles over 26 cycles
Duration - Up to 6 years
Participants are monitored for safety, disease status, and quality of life after treatment ends, including assessments of minimal residual disease and survival outcomes.
Regular visits every 3 months during the first year, then every 6 months thereafter
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
M
Mark-David Levin
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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