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Trial record 1 of 55 for:    cutaneous sclerosis
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Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lee, Stephanie, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier:
NCT01309997
First received: March 1, 2011
Last updated: May 10, 2016
Last verified: May 2016
Results First Received: September 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Graft Versus Host Disease
Systemic Scleroderma
Interventions: Drug: imatinib mesylate
Biological: 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
Arm I (Enzyme Inhibitor) Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
Arm II (Monoclonal Antibody) Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.

Participant Flow:   Overall Study
    Arm I (Enzyme Inhibitor)     Arm II (Monoclonal Antibody)  
STARTED     35     37  
Remained on First Arm Only     16     14  
Crossed Over to Second Arm     19     23  
COMPLETED     30     31  
NOT COMPLETED     5     6  
Adverse Event                 1                 0  
Death                 1                 3  
Lack of Efficacy                 2                 2  
Withdrawal by Subject                 1                 1  



  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
Arm I (Enzyme Inhibitor) Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
Arm II (Monoclonal Antibody) Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. TDuring the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
Total Total of all reporting groups

Baseline Measures
    Arm I (Enzyme Inhibitor)     Arm II (Monoclonal Antibody)     Total  
Number of Participants  
[units: participants]
  35     37     72  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     31     30     61  
>=65 years     4     7     11  
Gender  
[units: participants]
     
Female     18     22     40  
Male     17     15     32  



  Outcome Measures
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1.  Primary:   Significant Clinical Response   [ Time Frame: 6 months ]

2.  Secondary:   Patients Who Were Able to Taper Corticosteroids   [ Time Frame: 6 months ]

3.  Secondary:   Cumulative Incidence of Treatment Failure   [ Time Frame: 6 months ]

4.  Secondary:   Number of Patients Achieving Improvement in Cutaneous Sclerosis   [ Time Frame: 6 months ]

5.  Secondary:   Baseline Histopathologic Score in the Two Treatment Arms   [ Time Frame: Enrollment ]

6.  Secondary:   Patients With Any Percentage Decline in Any Grade of Sclerosis Without Increase in Percentage of Higher Grades of Sclerosis in Other Areas on the Vienna Skin Scale   [ Time Frame: 6 months ]

7.  Secondary:   Percentage of CD27+ B Cells in Responders (SCR) and Non-responders   [ Time Frame: 6 months ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Stephanie J. Lee MD MPH
Organization: FHCRC
phone: 206-667-6190
e-mail: sjlee@fhcrc.org


Publications of Results:

Responsible Party: Lee, Stephanie, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier: NCT01309997     History of Changes
Other Study ID Numbers: 2343.00
NCI-2011-00098 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RDCRN 6502 ( Other Identifier: Rare Diseases Clinical Research Network II )
2343.00 ( Other Identifier: Fred Hutchinson Cancer Research Center )
U54CA163438 ( US NIH Grant/Contract Award Number )
P30CA015704 ( US NIH Grant/Contract Award Number )
Study First Received: March 1, 2011
Results First Received: September 21, 2015
Last Updated: May 10, 2016
Health Authority: United States: Food and Drug Administration