Clinical Study of Chemoimmunotherapy With Fresh Frozen Plasma, High Dose Methylprednisolone 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
overall response rate
overall response rate after treated by FFP+HDMP+Rituximab regimen
Wei Xu, M.D., Ph.D.
Jiangsu Province Hospital
China: Ministry of Health