Campath-1H Plus Rituximab for CD52- and CD20- Positive Refractory or Relapsed Chronic Lymphoid Disorders

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00071396
First received: October 21, 2003
Last updated: August 1, 2012
Last verified: August 2012
Results First Received: September 25, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Lymphocytic Leukemia
Interventions: Drug: Campath-1H
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
Recruitment Period 10/21/02 - 3/27/09; all patients were registered at the University of Texas MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 48 patients enrolled, 41 patients were evaluable for response (2 patients withdrew before starting treatment and 2 were ineligible).

Reporting Groups
  Description
Campath-1H + Rituximab

Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.

Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22.


Participant Flow:   Overall Study
    Campath-1H + Rituximab  
STARTED     44  
COMPLETED     41 [1]
NOT COMPLETED     3  
Withdrawal by Subject                 1  
Physician Decision                 2  
[1] Evaluable for response.



  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
Campath-1H + Rituximab

Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.

Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22.


Baseline Measures
    Campath-1H + Rituximab  
Number of Participants  
[units: participants]
  44  
Age  
[units: years]
Median ( Full Range )
  59  
  ( 39 to 78 )  
Gender  
[units: participants]
 
Female     9  
Male     35  
Region of Enrollment  
[units: participants]
 
United States     44  



  Outcome Measures

1.  Primary:   Overall Response   [ Time Frame: After each 4 week course of treatment ]


  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: Alessandra Ferrajoli, MD, BS / Assistant Professor
Organization: The University of Texas M. D. Anderson Cancer Center
phone: 713-745-4613
e-mail: eharriso@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00071396     History of Changes
Other Study ID Numbers: ID02-368
Study First Received: October 21, 2003
Results First Received: September 25, 2009
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration