Combined Treatment With Fresh Frozen Plasma and Rituximab (Mabthera) in Patients With Advanced Refractory Chronic Lymphocytic Leukemia
Recruitment status was: Recruiting
|Advanced Refractory Chronic Lymphocytic Leukemia||Drug: Rituximab (Mabthera) , FFP (Fresh Frozen Plasma)||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Efficacy and Safety of Combined Treatment With Fresh Frozen Plasma and Rituximab (Mabthera) in Patients With Advanced Refractory Chronic Lymphocytic Leukemia. Single-arm Phase II Study. Analysis of Complement Activation Pathways.|
- To establish the efficacy of the combination of FFP and RTX as determined by response rate. Complete/Partial Response includes parameters: Physical Exam,Symptoms,Lymphocytes, Neutrophils, Platelets,Hb (g/dL),Bone marrow lymph [ Time Frame: 3 months ]
- Time to disease progression [ Time Frame: 6-12 months ]
- Time to re-treatment [ Time Frame: 6-12 months ]
- Safety of the combination treatment of FFP and RTX [ Time Frame: 6-12 months ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Experimental: Single Arm Study
Drug: Rituximab (Mabthera) , FFP (Fresh Frozen Plasma)
Rituximab (375 mg/m2) with FFP will be given every two weeks
Indolent B cell Non-Hodgkin's lymphoma patients show good responses to Rituximab, administered either alone or preferably with standard chemotherapy. The response to Rituximab of patients with CLL is inferior in comparison to other indolent B cell malignancies. The therapeutic approach of combining treatments with Rituximab and fresh frozen plasma (FFP) used by us first in one case and following the impressive response - in additional 2 patients, was undertaken on the basis of two observations.
We assumed, that the addition of FFP to Rituximab treatment would increase and/or restore the efficacy of Rituximab in advanced CLL patients that are resistant to therapy by correcting their abnormal complement system thus allowing improved complement activation and increase anti-leukemic activity.
The major aims of the study are: (1) To establish the efficacy of the combination of FFP and RTX as determined by response rate. (2) To elucidate the effector mechanism responsible for the efficacy of the FFP-Rituximab combination. The secondary aims of the study are (1) To establish the response duration of the combination of FFP and RTX as determined by time to progression. and time to re treatment (2) To determine the safety of the combined treatment.
The study is designed as a single-arm, phase II study evaluating the efficacy and safety of combined treatment with FFP and RTX in advanced refractory chronic lymphocytic leukemia, along with an analysis of the complement system associated parameters.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892827
|Holon, Israel, 58100|
|Contact: Abraham Klepfish, MD 972-35028778 email@example.com|
|Sub-Investigator: Goldstein Daniela, MD|
|Sub-Investigator: Gil Lugassy, Prof.|
|Sub-Investigator: Ami Schattner, Prof.|