Rituximab for the Primary Treatment of Denovo Extensive Chronic Graft Versus Host Disease (GVHD)

This study has been completed.
Sponsor:
Collaborator:
Blood and Marrow Transplant Group of Georgia
Information provided by (Responsible Party):
Northside Hospital, Inc.
ClinicalTrials.gov Identifier:
NCT01161628
First received: July 12, 2010
Last updated: March 22, 2016
Last verified: January 2016
Results First Received: December 16, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Graft-versus-host Disease
Intervention: 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
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
Rituxan

all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD

Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months.


Participant Flow:   Overall Study
    Rituxan  
STARTED     25  
COMPLETED     17  
NOT COMPLETED     8  
Death                 6  
Lack of Efficacy                 2  



  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
Rituxan

all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD

Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months.


Baseline Measures
    Rituxan  
Number of Participants  
[units: participants]
  25  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     19  
>=65 years     6  
Gender  
[units: participants]
 
Female     13  
Male     12  
Race/Ethnicity, Customized  
[units: participants]
 
White     21  
Black/African American     4  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Complete Response of cGVHD to Treatment.   [ Time Frame: 2 years ]

2.  Primary:   Rate of Overall Response of cGVHD to Treatment   [ Time Frame: 2 years ]

3.  Primary:   Rate of Partial Response of cGVHD to Treatment   [ Time Frame: 2 years ]

4.  Secondary:   Requirement for Systemic Corticosteroid Use   [ Time Frame: 2 years ]

5.  Secondary:   Time to Immunosuppression Withdrawal   [ Time Frame: 2 years ]

6.  Secondary:   Incidence of Overall Survival   [ Time Frame: 2 years ]

7.  Secondary:   Duration of Systemic Corticosteroid Use   [ Time Frame: 2 years ]

8.  Secondary:   Incidence of Disease-free Survival   [ Time Frame: 2 years ]

9.  Secondary:   Incidence of Non-relapse Mortality   [ Time Frame: 2 years ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Scott R. Solomon, MD (Principal Investigator)
Organization: Blood and Marrow Transplant Group of Georgia
phone: 404-255-1930
e-mail: ssolomon@bmtga.com


Publications:


Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT01161628     History of Changes
Other Study ID Numbers: NSH 893
Study First Received: July 12, 2010
Results First Received: December 16, 2015
Last Updated: March 22, 2016
Health Authority: United States: Food and Drug Administration