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

This study has been terminated.
(terminated due to lack of accrual)
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT00290407
First received: February 9, 2006
Last updated: May 3, 2013
Last verified: May 2013
Results First Received: May 3, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia, Lymphocytic, Chronic
Lymphoma, Small Lymphocytic
Interventions: Drug: Rituximab
Dietary Supplement: Beta-Glucan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
RITUXIMAB PLUS ORAL Β-GLUCAN No text entered.

Participant Flow:   Overall Study
    RITUXIMAB PLUS ORAL Β-GLUCAN  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
RITUXIMAB PLUS ORAL Β-GLUCAN No text entered.

Baseline Measures
    RITUXIMAB PLUS ORAL Β-GLUCAN  
Number of Participants  
[units: participants]
  2  
Age, Customized  
[units: participants]
 
Over 18 years of age     2  
Gender  
[units: participants]
 
Female     2  
Male     0  



  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Blood Specimens Will be Collected to Measure Immunologic Effect   [ Time Frame: at weeks 4, 8, 12, and at month 6 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated, results data not available  


Results Point of Contact:  
Name/Title: Roger H Herzig, MD
Organization: James Graham Brown Cancer Center
phone: 502/396-3119
e-mail: rhherz01@louisville.edu


No publications provided


Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00290407     History of Changes
Other Study ID Numbers: 008.06, BCC-HEM-06-001
Study First Received: February 9, 2006
Results First Received: May 3, 2013
Last Updated: May 3, 2013
Health Authority: United States: Food and Drug Administration