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

NCT00290407 | Terminated Phase 2 Results DMC

• 2 other identifiers: 008.06BCC-HEM-06-001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Leukemia, Lymphocytic, Chronic; Lymphoma, Small Lymphocytic

Keywords

chronic lymphocytic leukemia; small lymphocytic lymphoma; rituximab; beta-glucan

Outcome Measures

Primary Outcomes (1)

• CT Scan to Measure Clinical Effect (Response)

  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 Outcomes (1)

• Blood Specimens Will be Collected to Measure Immunologic Effect

  at weeks 4, 8, 12, and at month 6

Interventions

Rituximab DRUG

375 mg/m2, IV (in the vein), once a week for 4 weeks

Also known as: Rituxan

Beta-Glucan DIETARY_SUPPLEMENT

250 mg, orally (tablet), three times a day for 9 weeks

Also known as: Imucell WGP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Related Links

• James Graham Brown Cancer Center

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab; beta-Glucans

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Glucans; Polysaccharides; Carbohydrates

Limitations and Caveats

Study terminated, results data not available

Results Point of Contact

• Title: Roger H Herzig, MD
• Organization: James Graham Brown Cancer Center

rhherz01@louisville.edu

502/396-3119

Study Officials

• Roger H Herzig, MD

  James Graham Brown Cancer Center/University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: March 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 4, 2018
• Results First Posted: June 24, 2013

Record last verified: 2018-04

Locations

US (1)