Spots Global Cancer Trial Database for Trial of FFP+HDMP+Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Trial of FFP+HDMP+Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia
Official Title: Clinical Study of Chemoimmunotherapy With Fresh Frozen Plasma, High Dose Methylprednisolone and Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia
Study ID: NCT01670812
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Shandong Provincial Hospital, Jinan, Shandong, China
TongJi Medical University affiliated TongJi Hospital, Shanghai, Shanghai, China
West China School of Medicine, West China Hospital, Sichuan University, Chendu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital, TianJin, Tianjin, China
Contact Details
Name: Wei Xu, M.D., Ph.D.
Affiliation: The First Affiliated Hospital with Nanjing Medical University
Role: PRINCIPAL_INVESTIGATOR
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