Alemtuzumab and Rituximab in Treating Patients With High-Risk, Early-Stage Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00436904
First received: February 15, 2007
Last updated: November 21, 2011
Last verified: November 2011
Results First Received: September 16, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Drug: Alemtuzumab
Drug: Rituximab

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Alemtuzumab + Rituximab Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)

Participant Flow:   Overall Study
    Alemtuzumab + Rituximab  
STARTED     30  
COMPLETED     30  
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 + Rituximab Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)

Baseline Measures
    Alemtuzumab + Rituximab  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 29 to 77 )  
Gender  
[units: participants]
 
Female     10  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     30  
Performance Score [1]
[units: participants]
 
0 - Fully Active     27  
1 - Ambulatory, restricted strenuous activity     3  
[1] Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Confirmed Response, Defined as Objective Complete Remission or Partial Remission for a Duration of at Least 2 Months   [ Time Frame: Up to 6 months ]

2.  Primary:   Number of Participants With Treatment Related Adverse Events   [ Time Frame: Weekly for first 6 weeks, then monthly for 6 months, then at 9 and 12 months post registration ]

3.  Secondary:   Time to Response   [ Time Frame: Registration to first response (up to 5 years) ]

4.  Secondary:   Duration of Response   [ Time Frame: Up to 5 years ]

5.  Secondary:   Survival   [ Time Frame: Death or last follow-up (up to 5 years) ]

6.  Secondary:   Time to Disease Progression   [ Time Frame: Time from registration to progression (up to 5 years) ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Clive Zent
Organization: Mayo Clinic
phone: 507-284-5362
e-mail: zent.clive@mayo.edu


Publications of Results:

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00436904     History of Changes
Other Study ID Numbers: CDR0000529809, P30CA015083, MC038G, 801-04, 106.G0309, U3023s
Study First Received: February 15, 2007
Results First Received: September 16, 2011
Last Updated: November 21, 2011
Health Authority: United States: Food and Drug Administration