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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: December 19, 2012
Last verified: December 2012
History of Changes
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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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) ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab   [ Time Frame: Up to 9 months ]
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3.  Secondary:   2 Year Progression Free Survival   [ Time Frame: 2 years from registration ]
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4.  Secondary:   2 Year Survival   [ Time Frame: 2 years from registration ]
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5.  Secondary:   Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab   [ Time Frame: 6 weeks beginning at study week 36 ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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  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
No text entered.  


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


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00098670     History of Changes
Other Study ID Numbers: NCI-2012-02812, CALGB 10101, U10CA031946, CDR0000398139
Study First Received: December 7, 2004
Results First Received: November 5, 2012
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration