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

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 phase II trial.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
BE-Antwerpen-ZNASTUIVENBERG
NOT_YET_RECRUITING
Antwerp
BE-Roeselare-AZDELTA
NOT_YET_RECRUITING
Roeselare
Denmark
DK-Aalborg-ALBOGUH
NOT_YET_RECRUITING
Aalborg
DK-Copenhagen-RIGSHOSPITALET
RECRUITING
Copenhagen
DK-Odense-OUH
NOT_YET_RECRUITING
Odense
Germany
DE-Berlin-HELIOSBERLINBUCH
NOT_YET_RECRUITING
Berlin
DE-Köln-UKKOELN
NOT_YET_RECRUITING
Cologne
DE-Freiburg-UNIKLINIKFREIBURG
NOT_YET_RECRUITING
Freiburg Im Breisgau
DE-Greifswald-UNIGREIFSWALD
NOT_YET_RECRUITING
Greifswald
DE-Munster-GEMEINSCHAFTSPRAXIS
NOT_YET_RECRUITING
Münster
DE-Stuttgart-RBK
NOT_YET_RECRUITING
Stuttgart
DE-Ulm-UNIKLINKULM
NOT_YET_RECRUITING
Ulm
Netherlands
NL-Den Bosch-JBZ
NOT_YET_RECRUITING
's-hertogenbosch
NL-Alkmaar-NWZ
NOT_YET_RECRUITING
Alkmaar
NL-Amersfoort-MEANDERMC
NOT_YET_RECRUITING
Amersfoort
NL-Amsterdam-AMC
NOT_YET_RECRUITING
Amsterdam
NL-Dordrecht-ASZ
NOT_YET_RECRUITING
Dordrecht
NL-Ede-ZGV
NOT_YET_RECRUITING
Ede
NL-Eindhoven-CATHARINA
NOT_YET_RECRUITING
Eindhoven
NL-Groningen-UMCG
NOT_YET_RECRUITING
Groningen
NL-Leeuwarden-MCL
NOT_YET_RECRUITING
Leeuwarden
NL-Den Haag-HAGA
NOT_YET_RECRUITING
The Hague
NL-Tilburg-ETZ
NOT_YET_RECRUITING
Tilburg
NL-Utrecht-UMCUTRECHT
NOT_YET_RECRUITING
Utrecht
Contact Information
Primary
Arnon Kater
a.p.kater@amsterdamumc.nl
+31 6-11491753
Backup
Mark-David Levin
m-d.levin@asz.nl
Time Frame
Start Date: 2024-04-10
Estimated Completion Date: 2032-11
Participants
Target number of participants: 112
Treatments
Experimental: Arm A
6 cycles epcoritamab + 26 cycles venetoclax
Experimental: Arm B
12 cycles epcoritamab + 26 cycles venetoclax
Sponsors
Collaborators: Nordic CLL Study Group, German CLL Study Group
Leads: Stichting Hemato-Oncologie voor Volwassenen Nederland

This content was sourced from clinicaltrials.gov