Ofatumumab With High Dose Methylprednisone Followed by Ofatumumab and Alemtuzumab in 17p CLL
Condition: CLL; SLL
Intervention: Ofatumumab; High-Dose Methylprednisolone; Alemtuzumab
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Alemtuzumab; Ofatumumab; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 17p Deletion CLL

Summary:

      The main purpose of this study is to examine how two separate groups of 17p deletion Chronic
      lymphocytic leukemia (CLL) participants respond to sequential treatment with this particular
      combination of drugs. The two groups are those participants who have previously received
      treatment for their CLL and those who have not yet received any treatment. The combination of
      drugs is Ofatumumab and High-Dose Methylprednisolone (HDMP) first followed by Ofatumumab and
      Alemtuzumab. All three drugs are FDA approved and have known activity in treating 17p CLL. We
      hope that by combining these drugs together in this study, they will have more benefit than
      each one alone and that the subjects' CLL will be significantly impacted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented CLL/SLL

          -  17p deletion by FISH in 20% or more nuclei on peripheral blood, bone marrow or lymph
             node

          -  Normal organ function

        Exclusion Criteria:

          -  Pregnant or breast feeding

          -  Current active hepatic or biliary disease

          -  Chronic or current infectious disease requiring systemic antibiotics, antifungal, or
             antiviral treatment such as, but not limited to, chronic renal infection, tuberculosis
             and active Hepatitis C

          -  History of significant cerebrovascular disease in the past 6 months or ongoing event
             with active symptoms or sequelae

          -  Other past or current malignancy. Participants who have been free of malignancy for at
             least 2 years, or who have a history of completely resected non-melanoma skin cancer
             or successfully treated in situ carcinoma are eligible.

          -  Known HIV positive

          -  Clinically significant cardiac disease including unstable angina, acute myocardial
             infarction within 6 months prior to study entry, congestive heart failure, and
             arrhythmia unless controlled by therapy, with the exception of extra systoles or minor
             conduction abnormalities.

          -  Significant concurrent uncontrolled medical conditions 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 subject.

          -  Positive serology for Hepatitis B or C

          -  History of allergic reactions attributed to ofatumumab.