A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With CLL

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 15, 2019

Primary Completion Date

December 15, 2022

Study Completion Date

December 30, 2027

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

FCR and Ibrutinib

"Induction treatment:~Patients \<65 y and without significant comorbidities are given FCR 1or 2 courses (If patients' white blood cell count \<10×10\^9/L after first course, the second course can be saved). Then, patients takes ibrutinib orally for 3 months alternating with FCR in 2 cylcles.~1. FCR: F(Fludarabine):25mg/m2·d,d1-3; C(Cyclophosphamide):CTX 250mg /m2·d,d1-3; R(Rituximab):375mg/m2 d0(first course),500mg/m2 d0(subsequent courses);~2. Ibrutinib:420mg/d"

DRUG

BR and Ibrutinib

"Induction treatment:~Patients ≥65y and ≤75 y or \<65 y but with comorbidities, are given BR 1or 2 courses (If patients' white blood cell count drop to below10×10\^9/Lafter first course, the second course can be saved). Then, patients takes ibrutinib orally for 3 months alternating with BR in 2 cylcles. 1.BR: B(Bendamustine):90mg/m2·d,d1-2; R(Rituximab):375mg/m2 d0(first course),500mg/m2 d0(subsequent courses); 2. Ibrutinib: 420mg/d"

DRUG

Ibrutinib and Thalidomide

"Maintenance treatment:~After induction treatment, recommend ( but not mandatory) Ibrutinib or thalidomide monotherapy(according to patients preferrance) for MRD-positive patients.For MRD-negative patients, recommend ( but not mandatory) no maintenance therapy."

Trial Locations (1)

30020

RECRUITING

Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER