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

April 2, 2018 updated by: University of Louisville

Phase II Study of Rituximab Plus B-Glucan in Patients With Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CT Scan to Measure Clinical Effect (Response)
Time Frame: 3 months after starting treatment, 6 months after starting treatment, and every 6 months (after completing treatment) until disease progression
Study terminated, results data not available
3 months after starting treatment, 6 months after starting treatment, and every 6 months (after completing treatment) until disease progression

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood Specimens Will be Collected to Measure Immunologic Effect
Time Frame: at weeks 4, 8, 12, and at month 6
at weeks 4, 8, 12, and at month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center

Investigators

  • Principal Investigator: Roger H Herzig, MD, James Graham Brown Cancer Center/University of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria

February 9, 2006

First Posted (ESTIMATE)

February 13, 2006

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2018

Last Update Submitted That Met QC Criteria

April 2, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 008.06
  • BCC-HEM-06-001 (OTHER: James Graham Brown Cancer Center Clinical Trials Office)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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