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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:
ClinicalTrials.gov Identifier:
NCT00290407
First Posted: February 13, 2006
Last Update Posted: June 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
Results First Submitted: May 3, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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


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


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



Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00290407     History of Changes
Other Study ID Numbers: 008.06
BCC-HEM-06-001 ( Other Identifier: James Graham Brown Cancer Center Clinical Trials Office )
First Submitted: February 9, 2006
First Posted: February 13, 2006
Results First Submitted: May 3, 2013
Results First Posted: June 24, 2013
Last Update Posted: June 24, 2013