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

Primary Purpose

Leukemia, Lymphocytic, Chronic, Lymphoma, Small Lymphocytic

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rituximab
Beta-Glucan
Sponsored by
University of Louisville
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Lymphocytic, Chronic focused on measuring chronic lymphocytic leukemia, small lymphocytic lymphoma, rituximab, beta-glucan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • James Graham Brown Cancer Center

Outcomes

Primary Outcome Measures

CT Scan to Measure Clinical Effect (Response)
Study terminated, results data not available

Secondary Outcome Measures

Blood Specimens Will be Collected to Measure Immunologic Effect

Full Information

First Posted
February 9, 2006
Last Updated
April 2, 2018
Sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00290407
Brief Title
Rituximab Plus Beta-Glucan in Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL)
Official Title
Phase II Study of Rituximab Plus B-Glucan in Patients With Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
terminated due to lack of accrual
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine how well subjects respond to treatment with Rituximab plus Beta-Glucan.
Detailed Description
Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in adults. CLL is a cancer of the B-lymphocytes, which make antibodies that help protect the body against harmful foreign substances, such as bacteria and viruses. Similar to CLL, small lymphocytic lymphoma (SLL) is a less-common cancer of the B-lymphocytes. In SLL, the abnormal lymphocytes mainly affect the lymph nodes; in CLL, the abnormal lymphocytes mainly affect the blood and bone marrow. Current drug therapies for CLL/SLL are known to increase the severity of pre-existing low blood cell counts, which in turn increase the risk of infections in patients. Research to improve the safety and effectiveness of CLL/SLL therapy is currently ongoing. One such therapy being investigated is Rituximab. Rituximab is a type of drug known as a therapeutic antibody. Therapeutic antibodies are laboratory-created substances that attach onto a protein on the surface of a cell. After binding to the cell, the therapeutic antibody can block the growth of the tumor and/or trigger the body's immune system to attack the target, and can also sensitize a cancer cell to chemotherapy. Rituximab is approved by the Food and Drug Administration (FDA) for the treatment of CLL/SLL. Beta-Glucan (Imucell WGP) is an over-the-counter dietary supplement that enhances the body's immune system. ImucellTM WGP is extracted from food-grade baker's yeast, which is permitted for use in food by the FDA. Animal studies have shown that Imucell WGP helps trigger the white blood cells to destroy cancer cells. Other animal studies combining Rituximab with Imucell WGP have shown greater tumor regression and tumor-free survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic, Chronic, Lymphoma, Small Lymphocytic
Keywords
chronic lymphocytic leukemia, small lymphocytic lymphoma, rituximab, beta-glucan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
375 mg/m2, IV (in the vein), once a week for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Beta-Glucan
Other Intervention Name(s)
Imucell WGP
Intervention Description
250 mg, orally (tablet), three times a day for 9 weeks
Primary Outcome Measure Information:
Title
CT Scan to Measure Clinical Effect (Response)
Description
Study terminated, results data not available
Time Frame
3 months after starting treatment, 6 months after starting treatment, and every 6 months (after completing treatment) until disease progression
Secondary Outcome Measure Information:
Title
Blood Specimens Will be Collected to Measure Immunologic Effect
Time Frame
at weeks 4, 8, 12, and at month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger H Herzig, MD
Organizational Affiliation
James Graham Brown Cancer Center/University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Links:
URL
http://browncancercenter.org
Description
James Graham Brown Cancer Center

Learn more about this trial

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

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