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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00892827
• Date of registration: 04/05/2009
• Primary sponsor: Wolfson Medical Center
• Public title: Combined Treatment With Fresh Frozen Plasma and Rituximab (Mabthera) in Patients With Advanced Refractory Chronic Lymphocytic Leukemia
• Scientific 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.
• Date of first enrolment: April 2009
• Target sample size: 10
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00892827
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Israel

Contacts

• Name: Abraham Klepfish, MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced Refractory Chronic Lymphocytic Leukemia

Intervention(s)

Drug: Rituximab (Mabthera) , FFP (Fresh Frozen Plasma)

Primary Outcome(s)

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]

Secondary Outcome(s)

Safety of the combination treatment of FFP and RTX [Time Frame: 6-12 months]

Time to disease progression [Time Frame: 6-12 months]

Time to re-treatment [Time Frame: 6-12 months]

Secondary ID(s)

AK- 01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors