Campath in Chronic GVHD

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: NCT00495755
Recruitment Status : Completed
First Posted : July 3, 2007
Results First Posted : August 9, 2013
Last Update Posted : August 9, 2013
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Chronic Graft-vs.-Host Disease
Intervention: Drug: Alemtuzumab (Campath)

  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
Campath (Alemtuzumab) 3 dose cohorts entered

Participant Flow:   Overall Study
    Campath (Alemtuzumab)
Adverse Event                3 

  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
Campath (Alemtuzumab) No text entered.

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

  Outcome Measures

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

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: Corey S. Cutler, MD, MPH, FRCP(C)
Organization: Dana-Farber Cancer Institute
phone: 617-632-5946

Responsible Party: Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute Identifier: NCT00495755     History of Changes
Other Study ID Numbers: DFCI 07-057
First Submitted: July 2, 2007
First Posted: July 3, 2007
Results First Submitted: April 14, 2013
Results First Posted: August 9, 2013
Last Update Posted: August 9, 2013