The purpose of this study is to investigate efficacy and safety of fresh frozen plasma(FFP), high dose methylprednisolone(HDMP) and rituximab for ultra-high risk chronic lymphocytic leukemia.
Chronic lymphocytic leukemia remains incurable and particularly in ultra-high risk subgroup, and the prognosis of these patients is still dismal. This is a phase III, multicenter perspective clinical trial of combination of fresh frozen plasma(FFP), high dose methylprednisolone(HDMP) and rituximab for ultra-high risk chronic lymphocytic leukemiaThe. The main purpose of this study is to investigate efficacy and safety of this combinated regimen in subgroup of CLL patients. All the enrolled patients will be followed during and after the treatment period up to one year. Interim and final evaluation will be done after each cycle of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
This is a single arm, multicenter clinical trial, and the regimen including Fresh frozen plasma 400ml IV day0, Rituximab: 375 mg/m2 IV day0(after infusion of FFP), methylprednisolone 1g/m2(up to 1.5g) IV day1-day5
The First affiliated Hospital of AnHui Medical Universtiy
Hefei, Anhui, China
RECRUITINGTongJi Hospital
Wuhan, Hubei, China
overall response rate
overall response rate after treated by FFP+HDMP+Rituximab regimen
Time frame: one year
progression free survival
progression free survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients.
Time frame: one year
overall survival
overall survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients
Time frame: one year
Number of Participants with Adverse Events
Number of Participants with Adverse Events, and evaluated standard is according to common terminology criteria adverse events(CTCAE) version 4.0
Time frame: up to 30 days after last dose of treatment
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ChangZhou First People's Hospital
Changzhou, Jiangsu, China
RECRUITINGChangZhou No.2 People's Hospital
Changzhou, Jiangsu, China
RECRUITINGHuaiAn First People's Hospital
HuaiAn, Jiangsu, China
RECRUITINGNanJing First People's Hospital
Nanjing, Jiangsu, China
RECRUITINGJiangSu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGJiangSu Province Hospital of TCM
Nanjing, Jiangsu, China
RECRUITINGWuXi People's Hospital
Wuxi, Jiangsu, China
RECRUITINGZhenJiang First People's Hospital
Zhenjiang, Jiangsu, China
RECRUITING...and 4 more locations