Can a Three-Drug combo outsmart High-Risk CLL?

NCT ID NCT07738887

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This phase 2 trial is testing whether adding a new immune-boosting drug, epcoritamab, to two existing targeted therapies (ibrutinib and venetoclax) can improve outcomes for people with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have TP53 alterations. These genetic changes make the disease harder to treat and more likely to progress. The study will give participants the drugs in a sequence, starting with ibrutinib alone, then adding venetoclax, and finally epcoritamab, with the goal of achieving deep remissions (complete response with undetectable minimal residual disease) while using a fixed treatment duration. The trial will also monitor safety and tolerability in this high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
A combination of three drugs: ibrutinib (a targeted therapy), venetoclax (a BCL-2 inhibitor), and epcoritamab (a bispecific antibody that helps immune cells attack cancer).
What this could lead to
If successful, this combination could offer a more effective, fixed-duration treatment for a high-risk form of CLL, potentially leading to deeper and longer-lasting remissions without continuous therapy.
What could go wrong
This is a phase 2 trial with a small number of participants, so results may not be conclusive. The triple-drug regimen may cause significant side effects, and not all patients may respond as hoped.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AP-HP Pitié Salpêtrière

    Paris, 75013, France

  • AP-HP Saint-Louis

    Paris, 75010, France

  • CHU DE Montpellier

    Montpellier, 34090, France

  • CHU d'ANGERS

    Angers, 49100, France

  • CHU de Bordeaux HOPITAL HAUT-LEVEQUE

    Pessac, 33000, France

  • Centre Antoine Lacassagne

    Nice, 06100, France

  • Ch Du Mans-Centre de Cancerologie de La Sarthe

    Le Mans, 72100, France

  • Ch Metropole Savoie

    Chambéry, 73000, France

  • Ch Mont-de-Marsan - Hopital de Layné

    Mont-de-Marsan, 40000, France

  • Ch Rene Dubos

    Pontoise, 95300, France

  • Chd de Vendee

    La Roche-sur-Yon, 85000, France

  • Chr Metz-Thionville - Hopital de Mercy

    Metz, 57530, France

  • Chru de Strasbourg

    Strasbourg, 67000, France

  • Chu Estaing

    Clermont-Ferrand, 63100, France

  • Chu Lyon-Sud

    Lyon, 69310, France

  • Chu Pontchaillou

    Rennes, 35000, France

  • Chu Ucl Namur - Site Godinne

    Namur, 5000, Belgium

  • Chu de Lille - Hopital Claude Huriez

    Lille, 59000, France

  • Chu de Nantes

    Nantes, 44000, France

  • Chu de Poitiers - Hopital de La Miletrie

    Poitiers, 86000, France

  • Gustave Roussy Cancer Campus Grand Paris

    Paris, 94800, France

  • HELORA - Hôpital de La Louvière Site Jolimont

    La Louvière, 7100, Belgium

  • Institut D'Hematologie de Basse Normandie

    Caen, 14000, France

  • Institut Jules Bordet

    Brussels, 1070, Belgium

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne

    Saint-Etienne, 42270, France

  • Iuct Oncopole

    Toulouse, 31100, France

  • U.Z. LEUVEN - Campus GASTHUISBERG

    Leuven, 3001, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

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