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Leukemia, Lymphocytic, ChronicPhase 2NCT00290407

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

A Phase 2 study testing Rituximab and Beta-Glucan in people with Leukemia, Lymphocytic, Chronic and Lymphoma, Small Lymphocytic, run by University of Louisville at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Rituximab and Beta-Glucan
How many people
2 participants
Where
1 siteUnited States
Study dates
Mar 2006to Jan 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Rituximab, Beta-Glucan
Keywords
chronic lymphocytic leukemia, small lymphocytic lymphoma, rituximab, beta-glucan
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called Rituxan

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

  • Beta-GlucanDietary supplement

    Also called Imucell WGP

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CT Scan to Measure Clinical Effect (Response)

    Study terminated, results data not available

    Measured: 3 months after starting treatment, 6 months after starting treatment, and every 6 months (after completing treatment) until disease progression

Secondary outcomes (1)

  1. Blood Specimens Will be Collected to Measure Immunologic Effect

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionJan 2010
  4. Study completionJan 2010

Why it stopped: terminated due to lack of accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00290407
Sponsor's protocol ID
008.06
Other IDs
BCC-HEM-06-001
Status last verified
Apr 2018
First submitted
9 Feb 2006
Last updated
4 May 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab and Beta-Glucan in people with Leukemia, Lymphocytic, Chronic and Lymphoma, Small Lymphocytic, run by University of Louisville at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00290407.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.

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