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Campath in Chronic GVHD

This study has been completed.
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
Bayer
Information provided by (Responsible Party):
Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00495755
First received: July 2, 2007
Last updated: August 7, 2013
Last verified: August 2013
Results First Received: April 14, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Graft-vs.-Host Disease
Intervention: Drug: Alemtuzumab (Campath)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Campath (Alemtuzumab) 3 dose cohorts entered

Participant Flow:   Overall Study
    Campath (Alemtuzumab)
STARTED   13 
COMPLETED   10 
NOT COMPLETED   3 
Adverse Event                3 



  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 (Alemtuzumab) No text entered.

Baseline Measures
   Campath (Alemtuzumab) 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   12 
>=65 years   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (5) 
Gender 
[Units: Participants]
 
Female   5 
Male   8 
Region of Enrollment 
[Units: Participants]
 
United States   13 


  Outcome Measures
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1.  Primary:   The Maximum Tolerated Dose (MTD) of a Four-week Course of Alemtuxumab in Chronic GVHD for Patients With an Incomplete Response to Steroids   [ Time Frame: 12 weeks ]

2.  Secondary:   The Efficacy of a Four-week Course of Alemtuzumab in Patients With Steroid-refractory Chronic GVHD (cGVHD).   [ Time Frame: 12 weeks ]

3.  Secondary:   The Effect of Alemtuzumab Therapy on Parameters of Cellular and Humoral Immunity in the Late Post Transplant Period. This Information is Exploratory in Nature Only Due to the Heterogeneity of the Anticipated Patient Population.   [ Time Frame: 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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: Corey S. Cutler, MD, MPH, FRCP(C)
Organization: Dana-Farber Cancer Institute
phone: 617-632-5946
e-mail: cscutler@partners.org



Responsible Party: Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00495755     History of Changes
Other Study ID Numbers: DFCI 07-057
Study First Received: July 2, 2007
Results First Received: April 14, 2013
Last Updated: August 7, 2013