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

• Sponsor: University of Louisville (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00290407
• Collaborator: James Graham Brown Cancer Center (Other)
• Enrollment: 2
• Location: 1
• Duration (Months): 46.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Lymphocytic, Chronic; Lymphoma, Small Lymphocytic	Drug: Rituximab; Dietary Supplement: Beta-Glucan	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Rituximab Plus B-Glucan in Patients With Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL)
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Outcome Measures

Primary Outcome Measures

1. CT Scan to Measure Clinical Effect (Response) [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

Secondary Outcome Measures

1. Blood Specimens Will be Collected to Measure Immunologic Effect [at weeks 4, 8, 12, and at month 6]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	James Graham Brown Cancer Center	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• University of Louisville
• James Graham Brown Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• James Graham Brown Cancer Center

Publications

None provided.

• Responsible Party: University of Louisville
• ClinicalTrials.gov Identifier: NCT00290407
• Other Study ID Numbers: 008.06; BCC-HEM-06-001
• First Posted: Feb 13, 2006
• Last Update Posted: May 4, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by University of Louisville: chronic lymphocytic leukemia; small lymphocytic lymphoma; rituximab; beta-glucan
• Additional relevant MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Rituximab

Study Results

Participant Flow

Arm/Group Title	RITUXIMAB PLUS ORAL Β-GLUCAN
Arm/Group Description
Period Title: Overall Study
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	RITUXIMAB PLUS ORAL Β-GLUCAN
Arm/Group Description
Overall Participants	2
Age, Customized (participants) [Number]
Over 18 years of age	2 100%
Sex: Female, Male (Count of Participants)
Female	2 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RITUXIMAB PLUS ORAL Β-GLUCAN
Arm/Group Description
Measure Participants	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RITUXIMAB PLUS ORAL Β-GLUCAN
Arm/Group Description
Measure Participants	0

Adverse Events

Arm/Group Title	RITUXIMAB PLUS ORAL Β-GLUCAN
Arm/Group Description
All Cause Mortality
	RITUXIMAB PLUS ORAL Β-GLUCAN
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	RITUXIMAB PLUS ORAL Β-GLUCAN
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	RITUXIMAB PLUS ORAL Β-GLUCAN
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

Study terminated, results data not available

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.