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

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. Identifier: NCT00436904
Recruitment Status : Completed
First Posted : February 19, 2007
Results First Posted : October 26, 2011
Last Update Posted : December 1, 2011
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Drug: Alemtuzumab
Drug: Rituximab

  Participant Flow

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
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

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (29 to 77) 
[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

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

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

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

Publications of Results:

Responsible Party: Mayo Clinic Identifier: NCT00436904     History of Changes
Other Study ID Numbers: CDR0000529809
P30CA015083 ( U.S. NIH Grant/Contract )
MC038G ( Other Identifier: Mayo Clinic Cancer Center )
801-04 ( Other Identifier: Mayo Clinic IRB )
106.G0309 ( Other Identifier: Bayer and Berlex protocol )
U3023s ( Other Identifier: Genentech Protocol )
First Submitted: February 15, 2007
First Posted: February 19, 2007
Results First Submitted: September 16, 2011
Results First Posted: October 26, 2011
Last Update Posted: December 1, 2011