Advanced Refractory Chronic Lymphocytic Leukemia Clinical Trial
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.
| Verified date | September 2010 |
| Source | Wolfson Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | December 2010 |
| Est. primary completion date | July 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Wolfson MC | Holon |
| Lead Sponsor | Collaborator |
|---|---|
| Wolfson Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 3 months | Yes | |
| Secondary | Time to disease progression | 6-12 months | Yes | |
| Secondary | Time to re-treatment | 6-12 months | Yes | |
| Secondary | Safety of the combination treatment of FFP and RTX | 6-12 months | Yes |