We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efalizumab in Treating Patients With Graft-Versus-Host Disease of the Skin That Did Not Respond to Previous Steroids (NRR)

This study has been terminated.
(insufficient accrual/funding withdrawn)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00489216
First Posted: June 21, 2007
Last Update Posted: May 23, 2017
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.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
Results First Submitted: February 21, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Graft Versus Host Disease
Intervention: Biological: efalizumab

  Participant Flow
  Hide Participant Flow

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
Patients with evidence of an inflammatory, erythematous rash and skin biopsy consistent with cutaneous Graft-Versus-Host disease who had failed to improve after at least 4 weeks of methylprednisolone at 0.5mg/kg were eligible for enrollment.

Reporting Groups
  Description
Efalizumab

All patients on study will receive a total of 8 injections of efalizumab

efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at

1mg/kg


Participant Flow:   Overall Study
    Efalizumab
STARTED   2 
COMPLETED   1 
NOT COMPLETED   1 
Adverse Event                1 



  Baseline Characteristics
  Hide 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.
Patients with evidence of an inflammatory, erythematous rash and skin biopsy consistent with cutaneous Graft-Versus-Host disease who had failed to improve after at least 4 weeks of methylprednisolone at 0.5mg/kg were eligible for enrollment. Two patients were enrolled in the study.

Reporting Groups
  Description
Efalizumab

All patients on study will receive a total of 8 injections of efalizumab

efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at

1mg/kg


Baseline Measures
   Efalizumab 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      2 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1  50.0% 
Male      1  50.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      2 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Experiencing Adverse Events   [ Time Frame: 120 days ]

2.  Primary:   Degree of Skin Involvement by GVHD Using Two Digital Photography Techniques.   [ Time Frame: 120 days ]

3.  Primary:   Exploratory Assessment of the Staining of Cutaneous Tissues for LFA-1, ICAM-1, CD4, CD8, and Possibly CD20   [ Time Frame: 57 days ]

4.  Secondary:   Overall Complete Response Rate   [ Time Frame: 57 days ]

5.  Secondary:   Complete Cutaneous Response Rate   [ Time Frame: On study days 29 and 57 after 4 and 8 doses of weekly subcutaneous efalizumab ]

6.  Secondary:   Overall Hepatic Response Rate   [ Time Frame: On study days 29 and 57 after 4 and 8 doses of weekly subcutaneous efalizumab ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
The study was terminated early due to funding withdrawal/insufficient accrual limiting the data to be analyzed.


  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
phone: 919-966-1125
e-mail: Robin_V_Johnson@med.unc.edu



Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00489216     History of Changes
Other Study ID Numbers: LCCC 0605
First Submitted: June 20, 2007
First Posted: June 21, 2007
Results First Submitted: February 21, 2017
Results First Posted: April 6, 2017
Last Update Posted: May 23, 2017