Evaluation of the Safety and Efficacy of the Association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia with P53 Dysfunction

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

December 19, 2018

Primary Completion Date

June 17, 2023

Study Completion Date

December 19, 2025

Conditions
Relapsed or Refractory Chronic Lymphocytic Leukemia
Interventions
DRUG

Ibrutinib

Ibrutinib will be given at the fixed dose of 420 mg daily for the duration of treatment.

DRUG

Daratumumab

Daratumumab will be started 28 days after beginning of ibrutinib and will be administered at the standard dose of 16 mg/kg (divided over two days for the first infusion), then 16 mg/kg for the following infusions, weekly for 2 months, then every other week for 4 months and then once a month until progression or intolerance.

Trial Locations (24)

13273

Institut Paoli-Calmettes - Hématologie Clinique, Marseille

14033

CHU Caen - IHBN - Hématologie Clinique, Caen

25000

CHU Jean Minjoz - Hématologie, Besançon

31059

IUCT ONCOPOLE - Hématologie, Toulouse

33604

CHU Bordeaux - Hôpital Haut-Lévèque - CFM Maladies du sang, Pessac

34295

Hôpital Saint-Eloi - Hématologie Clinique, Montpellier

35033

CHU Pontchaillou - Hématologie Clinique BMT-HC, Rennes

37044

Hôpital Bretonneau - Hématologie et Thérapie Cellulaire, Tours

44093

CHU Hôtel Dieu - Hématologie Clinique, Nantes

51092

Hôpital Robert Debré - Hématologie Clinique, Reims

54511

Hôpitaux de Brabois - Hématologie Adulte, Vandœuvre-lès-Nancy

63000

CHU Estaing - Hématologie Clinique Adulte, Clermont-Ferrand

67098

ICANS, Strasbourg

69373

Centre Léon Bérard - Hématologie, Lyon

69495

CHLS - Lyon Pierre Bénite - Service Hématologie, Lyon

72000

Centre Hospitalier du Mans, Le Mans

74374

CH Annecy Genevois - Hématologie A3, Annecy

75651

Hôpital Pitié Salpétrière - Hématologie, Paris

76038

Centre Henri Becquerel - Service Hématologie Clinique, Rouen

80054

Chu Amiens Sud, Amiens

85925

CHD Vendée, La Roche-sur-Yon

86021

Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire, Poitiers

93009

Hôpital Avicenne - Centre de Recherche Clinique, Bobigny

388043

CHU Grenoble - Hématologie, Grenoble

All Listed Sponsors
collaborator

Janssen, LP

INDUSTRY

lead

French Innovative Leukemia Organisation

OTHER

NCT03734198 - Evaluation of the Safety and Efficacy of the Association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia with P53 Dysfunction | Biotech Hunter | Biotech Hunter