New drug combo takes aim at High-Risk leukemia

NCT ID NCT03734198

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 pilot study is testing whether combining two drugs, ibrutinib and daratumumab, can improve outcomes for people with relapsed or refractory chronic lymphocytic leukemia (CLL) that has a p53 gene problem. The 29 participants will take ibrutinib daily and receive daratumumab infusions on a schedule. The main goal is to see how many achieve a complete response within 12 months, while also monitoring safety.

What this could mean

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

Active substance
Ibrutinib and daratumumab
What this could lead to
If successful, this combination could offer a more effective treatment option for people with hard-to-treat CLL that has not responded to prior therapies.
What could go wrong
This is a small, early-phase pilot study with only 29 participants. The combination may not prove more effective than existing treatments and could cause side effects like infusion reactions or infections.

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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

  • CH Annecy Genevois - Hématologie A3

    Annecy, 74374, France

  • CHD Vendée

    La Roche-sur-Yon, 85925, France

  • CHLS - Lyon Pierre Bénite - Service Hématologie

    Lyon, 69495, France

  • CHU Bordeaux - Hôpital Haut-Lévèque - CFM Maladies du sang

    Pessac, 33604, France

  • CHU Caen - IHBN - Hématologie Clinique

    Caen, 14033, France

  • CHU Estaing - Hématologie Clinique Adulte

    Clermont-Ferrand, 63000, France

  • CHU Grenoble - Hématologie

    Grenoble, 388043, France

  • CHU Hôtel Dieu - Hématologie Clinique

    Nantes, 44093, France

  • CHU Jean Minjoz - Hématologie

    Besançon, 25000, France

  • CHU Pontchaillou - Hématologie Clinique BMT-HC

    Rennes, 35033, France

  • Centre Henri Becquerel - Service Hématologie Clinique

    Rouen, 76038, France

  • Centre Hospitalier du Mans

    Le Mans, 72000, France

  • Centre Léon Bérard - Hématologie

    Lyon, 69373, France

  • Chu Amiens Sud

    Amiens, 80054, France

  • Hôpital Avicenne - Centre de Recherche Clinique

    Bobigny, 93009, France

  • Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

    Tours, 37044, France

  • Hôpital Pitié Salpétrière - Hématologie

    Paris, 75651, France

  • Hôpital Robert Debré - Hématologie Clinique

    Reims, 51092, France

  • Hôpital Saint-Eloi - Hématologie Clinique

    Montpellier, 34295, France

  • Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

    Poitiers, 86021, France

  • Hôpitaux de Brabois - Hématologie Adulte

    Vandœuvre-lès-Nancy, 54511, France

  • ICANS

    Strasbourg, 67098, France

  • IUCT ONCOPOLE - Hématologie

    Toulouse, 31059, France

  • Institut Paoli-Calmettes - Hématologie Clinique

    Marseille, 13273, France

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