Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Lee, Stephanie
Study ID
NCT01309997
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • imatinib mesylate — DRUG
    Given PO
  • rituximab — BIOLOGICAL
    Given IV

Study Details

This randomized phase II trial is evaluating how well imatinib mesylate works compared to rituximab in treating cutaneous sclerosis in patients with chronic graft- versus-host disease (GVHD). Both imatinib and rituximab have been reported to decrease skin thickening and improve skin and joint flexibility in people with cutaneous sclerosis due to chronic GVHD.

Key Dates

Start date
Mar 31, 2011
Status verified
May 2016
Primary completion
Dec 31, 2014
Completion
Dec 31, 2015

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (enzyme inhibitor)
    Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity.
  • Experimental: 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.

Primary Outcome Measure

Significant Clinical Response [ Time Frame: 6 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Stanford University Hospitals and ClinicsStanfordCalifornia94305-
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Washington University School of MedicineSt LouisMissouri63110-
Roswell Park Cancer InstituteBuffaloNew York14263-
Weill Cornell Medical CollegeNew YorkNew York10065-
University of North CarolinaChapel HillNorth Carolina27599-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattleWashington98109-
Froedtert and the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic in Arizona· Scottsdale, AZStanford University Hospitals and Clinics· Stanford, CAH. Lee Moffitt Cancer Center and Research Institute· Tampa, FLWashington University School of Medicine· St Louis, MORoswell Park Cancer Institute· Buffalo, NYWeill Cornell Medical College· New York, NY

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