Status:
UNKNOWN
Combined Treatment With Fresh Frozen Plasma and Rituximab (Mabthera) in Patients With Advanced Refractory Chronic Lymphocytic Leukemia
Lead Sponsor:
Wolfson Medical Center
Conditions:
Advanced Refractory Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Chronic lymphocytic leukemia (CLL), an indolent disease of mature-looking B lymphocytes, is the most common leukemia in Israel and the Western world. The disease is associated with considerable morbid...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Diagnosis: advanced (Rai stage ≥2 or symptomatic stage 1) CLL Resistant to or relapsing after treatment with Fludarabine and/or Rituximab
- Lymphocyte count of 100,000 cells/mcl or higher.
- Time from last anti-leukemia treatment: 1 month or more
- Age: male or female over 18 years of age.
- Informed consent - obtained
Exclusion
- Lack of one or more of the inclusion criteria
- Known sensitivity to human plasma
- Known sensitivity to Rituximab (Mabthera)
- Active second malignant disease (other than non-melanoma skin cancer) \< 2 years prior to the study
- Active infectious disease \< 1 month prior to the study
- Hepatitis B serology: Hepatitis B surface antigen - positive
- Renal function: Creatinin \> 3 mg/dL
- Liver function: Liver enzymes less than x2 of the normal values
- Performance status: ECOG performance status 4
- Use of other investigational agent \< 30 days ago
- Known poor adherence to treatment plan
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00892827
Start Date
April 1 2009
End Date
December 1 2010
Last Update
September 14 2010
Active Locations (1)
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1
Wolfson MC
Holon, Holon, Israel, 58100