Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00098670
First received: December 7, 2004
Last updated: May 6, 2014
Last verified: December 2012
Results First Received: November 5, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: B-cell Chronic Lymphocytic Leukemia
Stage I Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Stage III Chronic Lymphocytic Leukemia
Stage IV Chronic Lymphocytic Leukemia
Interventions: Biological: alemtuzumab
Biological: rituximab
Drug: fludarabine phosphate

  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
Between January 2005 and December 2006, 103 participants were recruited.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant was deemed ineligible and is excluded from all analyses per study design.

Reporting Groups
  Description
Alemtuzumab Consolidation Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL

Participant Flow:   Overall Study
    Alemtuzumab Consolidation  
STARTED     102  
COMPLETED     102  
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.
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Reporting Groups
  Description
Alemtuzumab Consolidation Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL

Baseline Measures
    Alemtuzumab Consolidation  
Number of Participants  
[units: participants]
  102  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 23 to 82 )  
Gender  
[units: participants]
 
Female     27  
Male     75  
Region of Enrollment  
[units: participants]
 
United States     102  
Rai Stage [1]
[units: participants]
 
Stage 0     1  
Stage I-II     71  
Stage III-IV     30  
[1] Rai staging is a way to categorize the disease progression of chronic lymphocytic leukemia (CLL); higher stages reflect increasing severity. Rai Stage 0: Lymphocytosis only, Rai Stage I: Lymphocytosis and lymphadenopathy, Rai Stage II: Lymphocytosis and hepatomegaly +/- splenomegaly, Rai Stage III: Lymphocytosis and anemia, Rai Stage IV: Lymphocytosis and thrombocytopenia



  Outcome Measures
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1.  Primary:   Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab   [ Time Frame: Duration of treatment (up to 13.5 months) ]

2.  Secondary:   Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab   [ Time Frame: Up to 9 months ]

3.  Secondary:   2 Year Progression Free Survival   [ Time Frame: 2 years from registration ]

4.  Secondary:   2 Year Survival   [ Time Frame: 2 years from registration ]

5.  Secondary:   Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab   [ Time Frame: 6 weeks beginning at study week 36 ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Thomas Lin
Organization: The Ohio State University
e-mail: thomas.lin@osumc.edu


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00098670     History of Changes
Other Study ID Numbers: NCI-2012-02812, NCI-2012-02812, CDR0000398139, CALGB-10101, CALGB-10101, P30CA014236, U10CA031946
Study First Received: December 7, 2004
Results First Received: November 5, 2012
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration