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Clinical Study of Chemoimmunotherapy With Fresh Frozen Plasma, High Dose Methylprednisolone and Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
The First affiliated Hospital of AnHui Medical Universtiy
Hefei, Anhui, China
TongJi Hospital
Wuhan, Hubei, China
ChangZhou First People's Hospital
Changzhou, Jiangsu, China
ChangZhou No.2 People's Hospital
Changzhou, Jiangsu, China
HuaiAn First People's Hospital
HuaiAn, Jiangsu, China
NanJing First People's Hospital
Nanjing, Jiangsu, China
JiangSu Province Hospital
Nanjing, Jiangsu, China
JiangSu Province Hospital of TCM
Nanjing, Jiangsu, China
WuXi People's Hospital
Wuxi, Jiangsu, China
ZhenJiang First People's Hospital
Zhenjiang, Jiangsu, China
Start Date
January 1, 2012
Primary Completion Date
June 1, 2013
Completion Date
June 1, 2014
Last Updated
August 22, 2012
100
ESTIMATED participants
FFP+HDMP+Rituximab
DRUG
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
NCT05006716
NCT07277231
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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