Combined Treatment With Fresh Frozen Plasma and Rituximab (Mabthera) in Patients With Advanced Refractory Chronic Lymphocytic Leukemia

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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 morbidity and mortality, and is currently incurable. Rituximab (Mabthera) is a chimeric monoclonal antibody directed against CD20 antigen, present exclusively on B lymphocytes. Treatment with Rituximab is widely used in indolent B cell malignancies. However, the administration of Rituximab in CLL patients yields less successful results than in other indolent B cell malignancies, and even responding patients may become refractory. We hypothesized that the abnormalities in the complement system identified in CLL underlie the suboptimal response to Rituximab, since complement-dependent cell cytotoxicity is a major mechanism of Rituximab action. Following patient consent and Institutional Review Board approval, standard-dose Rituximab (375 mg/m2) will be administered, preceded by 2 units of FFP. This treatment will be repeated every 1-2 weeks for 4-6 cycles. The clinical and laboratory parameters, as well as adverse drug events, will be monitored.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wolfson Medical Center
• Treatments: Complement System Proteins; Rituximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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