50
Participants
Start Date
May 15, 2019
Primary Completion Date
December 15, 2022
Study Completion Date
December 30, 2027
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"
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"
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."
RECRUITING
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin
Institute of Hematology & Blood Diseases Hospital, China
OTHER