Rituximab Plus Beta-Glucan in Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL)
Condition: Leukemia, Lymphocytic, Chronic; Lymphoma, Small Lymphocytic
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Rituximab; Beta-Glucan
Intervention description: 375 mg/m2, IV (in the vein), once a week for 4 weeks; 250 mg, orally (tablet), three times a day for 9 weeks
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic lymphocytic leukemia; small lymphocytic lymphoma; rituximab; beta-glucan

Summary:

      The purpose of this study is to determine how well subjects respond to treatment with
      Rituximab plus Beta-Glucan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  definitive diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic
             Lymphoma (SLL)

          -  Patients with CLL must have active, progressive, or symptomatic Rai stage II, III, or
             IV disease. Patients with SLL must have active, progressive or symptomatic stages II,
             III, IV disease by the Ann Arbor Staging system. Patients with stage I CLL are
             eligible only if they have systemic symptoms requiring treatment.

          -  Patients may be treatment naïve, refractory to primary therapy, or relapsed not more
             than four times) and have measurable or assessable disease. Bone marrow involvement
             alone will not be acceptable as measurable disease in case of lymphoma.

          -  Prior therapies may include chemotherapy, radiation, autologous stem cell transplant,
             or Rituximab.

          -  Patients who have received therapy must be at least 4 weeks beyond prior standard
             chemotherapy including corticosteroids, 3 months beyond radiation therapy, and have
             recovered from significant toxicities from prior therapies

          -  age > 18 years

          -  life expectancy of greater than 12 weeks

          -  ECOG performance status 0, 1, or 2 (Karnofsky > 50%)

          -  adequate bone marrow function, as defined by: absolute neutrophil count > 1000/µl;
             platelets > 20,000/µl

          -  adequate liver function, as defined by: total bilirubin < 2, albumin > 2.5 g/dl, and
             no ascites; AST(SGOT), ALT(SGPT) & Alkaline Phosphatase < 2.5 x upper limit of normal

          -  adequate renal function, as defined by: creatinine < 2.5 mg/dl or a creatinine
             clearance > 30 mL/min (measured or estimated by the Cockcroft-Gault formula) for
             patients with creatinine levels above 2.5 mg/dl

          -  must have recovered from acute toxicities resulting from prior therapy to less than
             grade 1. Alopecia may not be resolved.

          -  ability to understand and willingness to sign a written informed consent document

        Exclusion Criteria:

          -  patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to study entry or who have not recovered from
             adverse events due to agents administered more than 4 weeks earlier

          -  severe autoimmune hemolytic anemia; CNS involvement (either parenchymal or meningeal);
             severe lymphoma-related symptoms requiring a rapid response to therapy (eg,
             respiratory compromise due to large effusions or airway obstruction, bowel
             obstruction, ureteral obstruction, and chylous ascites)

          -  patients receiving any other investigational agent(s)

          -  active second malignancy in the last 5 years, except for non-melanoma skin cancer or
             carcinoma-in-situ

          -  history of hypersensitivity reactions attributed to Beta-Glucan

          -  history of connective tissue or autoimmune disease

          -  patients receiving corticosteroids for any reason, except as a part of treatment for
             autoimmune hemolytic anemia or immune thrombocytopenia

          -  uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements