NCT04010968 - Evaluation of Risk-Adapted and MRD-Driven Strategy for Untreated Fit Patients With Intermediate Risk Chronic Lymphocytic Leukemia | Biotech Hunter

Enrollment

120

Participants

Timeline

Start Date

September 27, 2019

Primary Completion Date

April 3, 2023

Study Completion Date

January 30, 2025

Conditions

Intermediate Risk Chronic Lymphocytic LeukemiaFit PatientsRisk-Adapted and MRD-Driven Strategy

Interventions

DRUG

venetoclax and ibrutinib (I+VEN)

"The treatment will start with ibrutinib alone for 3 months (lead-in phase) from Month 1 to Month 3 and then venetoclax will be added from Month 4 with an initial ramp-up period.~The total duration of treatment with (I+VEN) will depend on the response achieved at Month 9:~* if BM MRD at M9 \< 0.01%, the treatment with (I+VEN) will be continued for 6 additional months until Month 15 and stopped then. MRD will be assessed at Month 15 (PB), Month 21 (PB) and Month 27 (PB and BM)~* if BM MRD at M9 ≥ 0.01%, the treatment with (I+VEN) will be continued for 18 additional months until Month 27 and stopped then, whatever the results of MRD assessments that will be performed at the same time points as above."

DRUG

FCR

"All patients will receive 6 cycles of FCR administered at 4 weeks intervals (D1 = D29) from Month 1 to Month 6.~6 cycles of FCR will be administered at 4 weeks intervals (D1 = D29) from Month 1 to Month 6."

Trial Locations (34)

14033

CHU Caen - IHBN - Hématologie Clinique, Caen

31059

IUCT ONCOPOLE - Hématologie, Toulouse

33076

Institut Bergonie, Bordeaux

33604

Bordeaux Pessac, Pessac

34295

Hôpital Saint Eloi, Montpellier

35033

CHU Pontchaillou - Hématologie Clinique BMT-HC, Rennes

35510

Hôpital Privé Sévigné, Cesson-Sévigné

37044

Hôpital Bretonneau - Hématologie et Thérapie Cellulaire, Tours

38028

GRENOBLE GHM - Institut Daniel Hollard, Grenoble

41000

CH BLOIS, Blois

42271

Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez

44093

CHU Hôtel Dieu - Hématologie Clinique, Nantes

44100

CHR ORLEANS - Hématologie, Orléans

51092

Chu Reims, Reims

54500

CHU Nancy Brabois, Vandœuvre-lès-Nancy

57085

Centre Hospitalier Regional Metz Thionville, Metz

59000

Hôpital Saint Vincent de Paul, Lille

63000

CHU Estaing - Hématologie Clinique Adulte, Clermont-Ferrand

64109

Ch Cote Basque, Bayonne

67098

Hôpital Hautepierre - Hématologie, Strasbourg

69373

Centre Léon Bérard - Hématologie, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

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

78157

Hôpital André Mignot, Versailles

85925

CHD Vendée, La Roche-sur-Yon

86021

Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire, Poitiers

91100

Centre Hospitalier Sud Francilien, Corbeil-Essonnes

93009

Hôpital Avicenne - Centre de Recherche Clinique, Bobigny

94000

Chu Creteil, Créteil

130009

Institut Paoli Calmette, Marseille

388043

CHU Grenoble - Hématologie, Grenoble