Rituximab Plus Beta-Glucan in Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL)

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James Graham Brown Cancer Center; University of Louisville
• Collaborators: James Graham Brown Cancer Center; University of Louisville
• Treatments: Rituximab

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