EL625 in Persistent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Condition: Lymphoma, Small Lymphocytic; Leukemia, Lymphocytic, Chronic
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: cenersen sodium; Rituximab; Cyclophosphamide; Fludarabine
Intervention description: 2.4 mg/kg/day as a continuous infusion over 24 hours starting on day one and ending on day 4; 375 mg/m2 on day 2; 250 mg/m2 on days 2, 3, and 4; 25 mg/m2 on days 2, 3, and 4
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia; EL625; cenersen

Summary:

      The purpose of this research study is to see if the investigational drug EL625, when combined
      with traditional chemotherapy (rituximab, fludarabine, and cyclophosphamide), is effective in
      Persistent Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of CLL/SLL who have received at least one prior treatment
             regimen and have persistent disease (i.e. any evidence of active disease). Patients
             with a chromosome 17 abnormality or a p53 mutation of any type may be enrolled without
             having received prior treatment.

          -  Patients must be 18 years of age or older.

          -  Patient has an estimated or measured creatinine clearance ≥30 ml/min at study
             enrollment.

          -  AST, ALT, total bilirubin < than 2.5 times the upper limit of normal.

          -  WBC > 1.5; ANC >500; Plt >50,000 unless documented as due to disease

          -  ECOG performance status of 0-2.

          -  Voluntary written informed consent before performance of any study-related procedure
             not part of normal medical care.

          -  Female subject is either post-menopausal or surgically sterilized or willing to use an
             acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine
             device, diaphragm with spermicide, condom with spermicide, or abstinence) for 2 weeks
             after administration of the study drug.

          -  Male subject agrees to use an acceptable method for contraception for the duration of
             the study therapy and for 2 weeks after administration of study drug.

        Exclusion Criteria:

          -  Female who is pregnant or lactating.

          -  Serious medical or psychiatric illness likely to interfere with participation in this
             clinical study.

          -  Patients with another malignancy within the last three years (from documentation of
             remission) other than basal or squamous cell skin cancer, resected early stage
             prostate cancer not requiring systemic treatment or CIS of the cervix or fully treated
             early stage prostate cancer.

          -  Significant cardiac or vascular events within 6 months: acute MI, unstable angina,
             severe peripheral vascular disease (ischemic pain at rest class 3 or worse,
             non-healing ulcers/wounds, congestive heart failure (NYHA class ≥ 2), uncontrolled
             cardiac arrhythmias, and disseminated intravascular coagulation.

          -  Patients who are unable to refrain from taking acetaminophen

          -  Investigational agent within 14 days of enrolling on the study.

          -  Patients unable or unwilling to refrain from antioxidants including vitamin A, vitamin
             C, vitamin E, lycopene, lutein, grape seed extract, pycnogenol, green tea extract, and
             the like.

          -  Patients who have received a prior allogenic stem cell transplant and have at least
             2.5% donor cells still evident on engraftment studies.