RecruitingPhase 1Phase 2NCT05791409

Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL

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


Sponsor

Stichting Hemato-Oncologie voor Volwassenen Nederland

Enrollment

112 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of venetoclax (a targeted pill that helps cancer cells self-destruct) and epcoritamab (an immunotherapy injection that directs the immune system to attack cancer) in people with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) — blood cancers that have returned or stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older with CLL or SLL that has come back or stopped responding to treatment - You have received at least one prior systemic treatment - Your CLL/SLL now requires treatment again - Your blood counts, liver, and kidney function are at acceptable levels - If you previously had venetoclax, it must have ended at least 24 months ago and your disease must not have progressed while on it **You may NOT be eligible if...** - You have never been treated for CLL/SLL before - You previously progressed while on venetoclax - You have active infections - You are pregnant or breastfeeding - Your organ function is too impaired to tolerate the treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEpcoritamab

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.

DRUGVenetoclax

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.


Locations(24)

BE-Antwerpen-ZNASTUIVENBERG

Antwerp, Belgium

BE-Roeselare-AZDELTA

Roeselare, Belgium

DK-Aalborg-ALBOGUH

Aalborg, Denmark

DK-Copenhagen-RIGSHOSPITALET

Copenhagen, Denmark

DK-Odense-OUH

Odense, Denmark

DE-Berlin-HELIOSBERLINBUCH

Berlin, Germany

DE-Köln-UKKOELN

Cologne, Germany

DE-Freiburg-UNIKLINIKFREIBURG

Freiburg im Breisgau, Germany

DE-Greifswald-UNIGREIFSWALD

Greifswald, Germany

DE-Munster-GEMEINSCHAFTSPRAXIS

Münster, Germany

DE-Stuttgart-RBK

Stuttgart, Germany

DE-Ulm-UNIKLINKULM

Ulm, Germany

NL-Den Bosch-JBZ

's-Hertogenbosch, Netherlands

NL-Alkmaar-NWZ

Alkmaar, Netherlands

NL-Amersfoort-MEANDERMC

Amersfoort, Netherlands

NL-Amsterdam-AMC

Amsterdam, Netherlands

NL-Dordrecht-ASZ

Dordrecht, Netherlands

NL-Ede-ZGV

Ede, Netherlands

NL-Eindhoven-CATHARINA

Eindhoven, Netherlands

NL-Groningen-UMCG

Groningen, Netherlands

NL-Leeuwarden-MCL

Leeuwarden, Netherlands

NL-Den Haag-HAGA

The Hague, Netherlands

NL-Tilburg-ETZ

Tilburg, Netherlands

NL-Utrecht-UMCUTRECHT

Utrecht, Netherlands

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NCT05791409


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