Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Ofatumumab + Fresh Frozen Plasma
Intervention MeSH terms: Ofatumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fresh Frozen Plasma; Complement; Monoclonal Antibody

Summary:

      It has been shown that many patients with lymphoma or chronic lymphocytic leukemia (CLL)have
      low levels of complement. Several drugs have been approved by the Food and Drug
      Administration (FDA) for use in this cancer. However, these drugs are often used as
      combination therapies which means two or more drugs are part of the treatment. Many people,
      especially elderly patients, cannot put up with the use of multiple drugs because of the side
      effects.

      The main purpose of this study is to see if patients respond to therapy with human plasma
      (known as fresh frozen plasma or FFP) and ofatumumab. Another purpose of the study is to find
      out if this therapy will increase chances of getting rid of leukemia. This study will also
      look at the levels of complement in your blood. The levels of complement may allow better
      understanding of whether increasing the levels of complement by giving FFP may help control
      leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a pathological diagnosis of B-cell CLL.

          -  Patients must have received prior rituximab therapy and must have recovered from all
             non-hematologic toxicities. (Previous radiation is allowed as long as patients have
             recovered from all treatment related toxicities).

          -  Patients must meet the following laboratory values:

               -  Hgb > 9.0 g/dl

               -  Platelets > 50,000/mm3

               -  Creatinine < 2.0 times the institutional upper limit of normal

               -  SGOT/SGPT < 2.5 times the institutional upper limit of normal

               -  Total Bilirubin <1. 5 times the institutional upper limit of normal

               -  Alkaline phosphatase <2.5 times upper limit of normal (unless due to disease
                  involvement of the liver or bone marrow)

          -  Patients must be at least 18 years of age.

          -  Patients must have a performance status of 0-2 by ECOG criteria.

          -  All patients must be informed of the investigational nature of this study and must
             sign and give written consent in accordance with institutional and federal guidelines.

        Exclusion Criteria:

          -  Subjects who have current active hepatic or biliary disease.

          -  Having received rituximab or rituximab-containing therapy within the prior 3 months.

          -  Treatment with any known therapeutic or experimental therapy within 4 weeks prior to
             enrollment, or currently participating in any other interventional clinical study.

          -  Other past or current malignancy.

          -  Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months
             prior to start of therapy.

          -  Chronic or current infectious disease requiring systemic antibiotics, antifungal, or
             antiviral treatment such as, but not limited to, chronic renal infection, chronic
             chest infection with bronchiectasis, tuberculosis and active Hepatitis C.

          -  History of significant cerebrovascular disease in the past 6 months or ongoing event
             with active symptoms or sequelae.

          -  Known HIV positive.

          -  Clinically significant cardiac disease including unstable angina, acute myocardial
             infarction within six months prior to randomization, congestive heart failure, and
             arrhythmia unless controlled by therapy, with the exception of extra systoles or minor
             conduction abnormalities.

          -  Significant concurrent, uncontrolled medical condition including, but not limited to,
             renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or
             psychiatric disease which in the opinion of the investigator may represent a risk for
             the patient.

          -  Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg.

          -  Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which
             case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the
             result.

          -  Pregnant or lactating women.

          -  Women of childbearing potential, including women whose last menstrual period was less
             than one year prior to screening, unable or unwilling to use adequate contraception
             from study start to one year after the last dose of protocol therapy.

          -  Male subjects unable or unwilling to use adequate contraception methods from study
             start to one year after the last dose of protocol therapy.

          -  Receiving warfarin.